Biosimilar News and Commentary – NEW BLOG

Despite biosimilars’ long availability, education remains inadequate and must reflect evolving FDA requirements, evidence, and expanded use. Stakeholders view education as a shared responsibility involving regulators, academia, manufacturers, and continuing education providers. However, limited curricula, resources, physician confidence, and patient communication challenges persist, leaving the FDA as the primary trusted educational source.

The fourth Biosimilar User Fee Agreement (BsUFA IV) negotiations were only recently concluded, and the result poses new opportunities for biosimilar manufacturers. At last week’s GRx+Biosims meeting, several sessions touched on the significant changes to the program.

Joining forces with a Chinese biologics company enabled Fresenius Kabi to obtain rights up for up to 37 biosimilar candidates over the next decade. Fresenius Kabi, a serious player in the US biosimilar arena, had been seeking ways to bolster its biosimilar pipeline, and it made quite a splash earlier this week. The company signed … Continue reading Fresenius Kabi Expands Biosimilar Pipeline With Deal for Next-Generation Molecules →

Samsung Bioepis’ deepening ties with Teva has yielded a new deal for its etanercept biosimilar Eticovo. Under the new agreement, Teva will obtain US commercialization rights to etanercept-ykro. The timing of Eticovo’s commercial launch in the US will be determined by Teva, accordin to the press release.

Pfizer’s trastuzumab and rituximab biosimilars have seen dramatic average sales price reductions, reaching up to 93% lower than competitors. Trazimera and Ruxience pricing dropped significantly, despite maintaining notable market shares in their categories. Additionally, Xbrane Biopharma received FDA approval for its ranibizumab biosimilar, Lucamzi, enhancing market competition.

The FDA’s removal of the phase 3 trial requirement for biosimilars paves the way for lower development costs, opening opportunities for new entrants in the market. Formycon’s FYB206, a pembrolizumab biosimilar, exemplifies this shift. Enhanced competition may lead to reduced prices and new biosimilar products being created.

At the Festival of Biologics in Basel, discussions centered on the removal of phase 3 trials for biosimilars, highlighting significant cost savings and its impact on competition. Experts emphasized the potential for biosimilars to enhance healthcare value, though access remains uneven. Regulatory changes could accelerate development and expand market opportunities for new entrants.

On October 1, Samsung Bioepis and Teva announced that they will be partners in bringing up to 6 more biosimilars to the North American and European markets. The October 1 press release by Samsung Bioepis and Teva was a further statement of shared biosimilar interests: They are extending their existing partnership to include what may … Continue reading New Expansion of Biosimilar Partnership: Samsung Bioepis and Teva Will Team up on Fasenra and Ilaris biosimilars, Plus 4 More →

With the publication of the GLOBE model final rule, CMS outlines exemptions that seem to reduce the value of the program significantly. It also specifies biosimilar impacts of GLOBE. As published in final rule form, the federal government’s Global Benchmark for Efficient Drug Pricing Model (GLOBE) seems a lot less significant than when it was … Continue reading Biosimilar Aspects of the GLOBE Final Rule   →

Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option. Waltz Health, a digital health company, … Continue reading Does the Direct-to-Employer Route for Biosimilars Make Sense? →

With regulators focused on streamlining the 351(k) biosimilar development, it makes sense to wonder if the 505(b)2 pathway is valid for biosimilar approval. Can discussions about streamlining biosimilar development reach into abbreviated approval pathways for small molecules? Based on a Stat News webinar I attended yesterday, they already have. What exactly are the differences between … Continue reading Is the 505(b)2 Pathway Viable for Biosimilars? →

Amgen became the first manufacturer to submit an application to the FDA for a nivolumab (Opdivo) biosimilar. It also was the first to be sued for patent infringement. Last week, Amgen became the first manufacturer to disclose that they submitted an application to the FDA for a nivolumab (Opdivo) biosimilar. In doing so, Amgen also … Continue reading First Opdivo Biosimilar FDA Application Submitted by Amgen →

Despite the barriers to biosimilar development, several pharmaceutical organizations are fully committed to their biosimilar future. Over the course of the next several months, BR&R will highlight some of these intriguing pipeline portfolios. We’re kicking it off in this post with Sandoz’s biosimilar pipeline; the company just announced a much broader pipeline initiative. Whereas some … Continue reading Sandoz’s Wide Biosimilar Pipeline Getting Much Wider →

Alvotech has a new vedolizumab BLA and new marketing partner, and Stelara biosimilars produced equivalent clinical outcomes to the reference product over 6 months of treatment. Alvotech’s Second Application for Vedolizumab Biosimilar and New Marketing Partner Alvotech announced that the FDA has accepted its 351(k) application for a prefilled syringe and autoinjector formulation of vedolizumab. … Continue reading Biosimilar Bytes: Alvotech Biosimilar News and 6-Month Ustekinumab Switching Outcomes →

Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors? This week, Teva received an appellate court ruling on the IRA Medicare Fair … Continue reading The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics →

Adalimumab biosimilar utilization account for more than 80% of the drug category, as AbbVie’s Humira revenues dry up. Although the numbers are hard to come by, it seems apparent that adalimumab biosimilar sales have pounded the reference product Humira into submission through the second quarter of 2026. AbbVie announced Humira net revenues of only $425,000,000 … Continue reading US Humira Sales Overwhelmed by Biosimilar Competition →

On July 31, Fresenius Kabi and Polpharma Biologics announced that its 351(k) application was accepted by both the FDA and the EMA for PB016, a proposed vedolizumab biosimilar candidate to Entyvio The second vedolizumab biosimilar candidate is now under review by the US FDA. On July 31, Fresenius Kabi announced that its 351(k) application was … Continue reading The Second Entyvio Biosimilar Is Under Review at FDA →

The 340B Rebate Pilot Program could give biosimilar makers a needed boost, as they lose revenues to the profit incentive of eligible covered entities. The 340B program has been a barrier for biosimilar products being dispensed in outpatient facilities. Forbes sites that branded drugs account for approximately 90% of 340B pharma sales, compared with 78% … Continue reading 340B Pilot Program Could Be Big Boon for Biosimilars →

A study by IQVIA finds that first prescription rejection rates were unchanged for the first MFP negotiated drugs after implementation in January. A notable study by IQVIA found that for the first drugs subject to Medicare maximum fair price (MFP) agreements, initial rejection rates were not significantly lower than before the new prices took effect … Continue reading MFP Agreements Don’t Guarantee Better Patient Access →

Biocon announced the launch of its Yesafili biosimilar, in competition now with Pavblu, for the aflibercept market. Dr. Reddy’s and its marketing partner Fresenius Kabi have received FDA approval for its rituximab biosimilar. Biocon Begins Marketing Its Aflibercept Biosimilar Yesafili Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Limited, said, “The commercial launch … Continue reading Biosimilar Bytes: Biocon’s Yesafili Launches and Dr. Reddy’s Rituximab Biosimilar Is Approved →

Our survey found that 87% of biosimilar products were associated with patient copay assistance programs that cut out-of-pocket costs to $5 or less. Physician perceptions of important financial assistance differences between biosimilars and reference products seem generally unfounded. The newly published edition of the Samsung Bioepis Biosimilar Market Report indicates that with few exceptions, biosimilar … Continue reading Are Biosimilar Patient Copay Assistance Programs Lacking? →

Trump’s desire to remove a drug tariff exemption for generics and biosimilars produced overseas is ill-conceived and truly damaging to these low-margin industries. The Trump administration seems to think that making generics and biosimilars more expensive to the health system and consumers alike is a great idea. On July 21, President Trump posted on social … Continue reading Trump Tariffs on Generics and Biosimilars: Utter Nonsense or Just Plain Stupidity? →

Proposals in the House and Senate, both titled the Expedited Access to Biosimilars Act, may officially remove the FDA’s requirement for clinical efficacy studies for biosimilar candidates. On July 15th, a new bipartisan bill was introduced into the House of Representatives that would expand access to biosimilars by modernizing the FDA’s biosimilar approval process. This … Continue reading Tracking Two Bills to Remove the Clinical Efficacy Study Requirement for Biosimilar Development →

The Federal Trade Commission has reached a tentative settlement with the Big 3 PBM Caremark, which should increase the PBM’s transparency and has the potential for further reducing the use of rebate-based pharmaceutical pricing models. In the latest salvo in the Federal Trade Commission’s (FTC’s) war on PBM practices, begun in 2024, it has reached … Continue reading Another Big 3 PBM Settles With FTC on Rebates, Passthroughs, and Price Spreads →

The FDA has approved the eighth pegfilgrastim biosimilar; now Accord BioPharma owns two of them: newly approved Ennumo and Udenyca Accord BioPharma and its parent company Intas Pharmaceuticals announced that had it received approval on July 9th for a new pegfilgrastim biosimilar, which it has dubbed Ennumo (pegfilgrastim-pccg). The new biosimilar has been approved for … Continue reading Are Two Pegfilgrastims for Accord BioPharma Better Than One? →

A focus on biosimilars will save individual state employee health plans a conservative average of over $17 million, based on net costs. A new survey from the Pacific Research Institute found that a greater focus on biosimilar utilization will save individual state employee health plans on average over $17 million each year, based on net … Continue reading Why State Employee Health Plans Should Push Hard for Biosimilar Use →

Janssen files BPCIA patent suit against an impending Alvotech golimumab biosimilar, and Samsung Bioepis releases positive phase 3 trial results Golimumab Patent Battle for Alvotech and Bio-Thera Biosimilars Alleging patent infringement, Janssen Biotech filed BPCIA litigation in US District Court for the Eastern District of Virginia against Alvotech involving AVT05, its golimumab biosimilar candidates. According … Continue reading Biosimilar Bytes: Golimumab Patent Litigation, Positive Keytruda Biosimilar Trial Results →

Samsung BIoepis announced that it has relaunched Byooviz US marketing efforts with Harrow, the ophthalmology product commercialization partner it signed last July; Lupin receives FDA approval for its own ranibizumab biosimilar. On July 1, Samsung Bioepis announced that the pause in marketing for its ranibizumab biosimilar Byooviz has come to a close, with the relaunch … Continue reading Samsung Bioepis Reboots Byooviz Marketing With Harrow at the Helm →

In 2026, is the definition of a biosimilar the same for countries’ drug regulatory systems around the globe? A recently published scoping survey attempted to answer the question. Although there has been a decade of interest in moving towards global biosimilar regulatory standards, we first must answer a more foundational question: Is the definition of … Continue reading When is a Biosimilar a Biosimilar? →

The Guangdong, China–based generics manufacturer and its commercialization partner Lanexa Biologics received FDA approval for their insulin glargine biosimilar Langlara. In addition to its insulin glargine product, which is approved in China, other biosimilars may follow based on Sunshine Lake’s other existing insulin formulations. Another insulin glargine biosimilar has joined the ranks of Semglee and … Continue reading Sunshine Lake Pharma and Lanexa Biologics Get Their First FDA Biosimilar Approval →

The first 351(k) application for a vedolizumab (Entyvio) biosimilar has been submitted by Alvotech. If approved, the biosimilar would be marketed by Teva. Alvotech also resubmitted biosimilar applications for golimumab and aflibercept. On June 8, Alvotech announced that the FDA has accepted its biologic licensing application for AVT16, a biosimilar candidate for the reference drug … Continue reading Alvotech Submits First Entyvio Biosimilar Application to FDA →

With the October 2025 launch of Tyruko (natalizumab), neurologists have now been exposed to three different biosimilar categories, and one has been around since before the COVID-19 pandemic.     It’s logical to assume that when a specialty is exposed to biosimilar competition for the first time, acceptance and uptake of the biosimilar might be slow. … Continue reading How Comfortable Are Neurologists With Biosimilar Prescribing? →

In reporting its 2026 first-quarter earnings, Amgen indicated a 37% reduction in Enbrel sales revenue compared with the first quarter of 2025. Was this related directly to the January 1 implementation of the MFP price for Enbrel or just a continuing trend in its sales? What does it mean for the etanercept biosimilars? On January … Continue reading The Effect of MFP on Enbrel Sales, and Biosimilar Implications →

The interchangeability designation for biosimilars has been a source of confusion, derision, and even change of philosophy for the FDA. Why is it still with us? I was asked most recently why on a new biosimilar approval, where the drug was granted the interchangeable designation, I did not report on it as part of the … Continue reading What Have I Got Against the Biosimilar Interchangeability Designation? Much. →

Bio-Thera Solutions and Accord Biopharma received an FDA approval on May 15, 2026 for the biosimilar forms of Simponi and Simponi Aria. Dubbed Immgolis and Immgolis Intri, this first-in-class golimumab biosimilar should be available before the end of 2026.   On May 15, the FDA approved the first golimumab biosimilars, Immgolis and Immgolis Intri (golimumab-sldi) … Continue reading First US Approval for a Golimumab Biosimilar: Immgolis and Immgolis Intri to Launch by End of 2026 →

CVS Caremark announced that after June 30, it will no longer cover Stelara for most commercial clients and instead cover two ustekinumab biosimilars, including its private-label version of Pyzchiva. Effective with its July 1, 2026 formulary update, CVS Caremark will officially drop from coverage the ustekinumab reference product Stelara and prefer both Pyzchiva and Yesintek … Continue reading CVS Caremark Drops Stelara Coverage in Favor of Biosimilars →

For the biosimilar industry, serious progress was made in streamlining biosimilar development, but little was finalized, under the leadership of now-former FDA Commissioner Dr. Marty Makary. With the resignation on May 12th of Marty Makary, MD, MPH, as FDA Commissioner, it is difficult to analyze his performance after a scant 13 months in office. For … Continue reading Will We Remember Marty Makary in 2030? →

Amneal has gone from purchasing a subsidiary to acquiring 100% of Kashiv Biosciences, LLC; and India-based generic drug maker Sun Pharmaceuticals is acquiring Organon. Amneal Pharmaceuticals to Buy Kashiv Biosciences for $1.1 Billion Over the past couple of years, Kashiv Biosciences, LLC has served as an R&D engine for Amneal Pharmaceuticals’ biosimilar commercialization business. Whereas … Continue reading Biosimilar Company Acquisitions: Amneal and Sun in Separate Deals Signal More Generic Drug Maker Participation →

In this post, we summarize market share and average sales price (ASP) trends for several notable biologic categories with biosimilar competition, courtesy of the Q2 2026 Samsung Bioepis Market Trend Report. Over the years, we’ve observed the effect of biosimilar competition on biologic pricing, generally in the form of ASP and wholesale average cost (WAC) … Continue reading More on the Dynamics of the Biosimilar Marketplace →

The latest Samsung Bioepis Biosimilar Market Report (Q2 2026) was released yesterday, and it reveals a host of intriguing movements in both price and market share of biosimilar agents. In this post, we’ll look at the oncology category. The movements of one of the most established drug categories—trastuzumab—caught my eye in the newest release of … Continue reading Market Share vs. ASP: Do Oncology Biosimilar Trends Make Sense? →

At the twice-yearly meeting of the Academy of Managed Care Pharmacy (AMCP), the job of the Government and Regulatory Affairs group is to brief members and attendees on the latest federal and state developments that affect health plan, pharmacy benefit management, and pharmacy in general. Much of this activity intersects with the biosimilar industry, as … Continue reading Pharmacy’s View on MFN, MFP, and Drinking From the Firehouse →

On April 2, the Trump administration announced a new round of tariffs, this time affecting the branded pharmaceutical industry. The threat of 100% tariffs on patented drug products and their active ingredients has the industry seeking to understand the explanations and its several exemptions. Yesterday, the White House issued a new set of tariffs on … Continue reading 100% Tariffs Slapped on Pharmaceutical Companies, With Many Exceptions: Circumventing the Supreme Court? →

In 2026, the number of EMA-approved and FDA-approved biosimilar drug categories are now even. However, the number of marketed US biosimilars is less than half of that in the EU. When looking at the approvals by the European Medicines Agency (EMA) of biosimilars since the initial approval back in 2006 for somatropin biosimilar, it becomes … Continue reading FDA vs. EMA Biosimilar Approvals, an Update →

Five early-stage biosimilar candidates from Samsung Bioepis will be marketed in various parts of the world by Sandoz, including SB36, for which Sandoz will hold marketing rights in the US. Samsung Bioepis, which had earlier this year announced a substantial biosimilar infusion to its pipeline, entered into a marketing agreement on March 18th with Sandoz … Continue reading Samsung Bioepis, Sandoz Forge Deeper Biosimilar Ties →

A recent study published in JAMA found that as the acquisition prices of bevacizumab, rituximab, and trastuzumab fell from 2020 to 2024, hospitals’ profits on each biosimilar purchase increased, and the uptake of these oncology biosimilars rose quickly. This could be an important lesson for the upcoming Keytruda and Opdivo biosimilar launches. Researchers from the … Continue reading As Oncology Biosimilar Acquisition Prices Fall for Hospitals, Biosimilar Adoption Rises   →

The FDA positions non-US-licensed reference products as adequate for clinical pharmacokinetic investigations and to reduce data redundancy The FDA on March 10th released new draft guidance for the biosimilar industry that begins to tie together some of the concepts in streamlining biosimilar development that has been discussed for some time now. The new guidance goes … Continue reading The FDA’s New Draft Guidance Contributes to Streamlined Biosimilar Development →

A summary of remarks on PBM reform and the FTC–ESI settlement by speakers at last month’s Association for Accessible Medicines’ Access 2026 conference. The Association for Accessible Medicines’ (AAM) Access 2026 conference in Miami February 23-25 was perfectly timed to take advantage of perhaps the most important health care—related events of the year: the passage … Continue reading Two Leaders’ Views on National PBM Reform: Biosimilar and ERISA Benefits →

Takeaways from discussions on the Trump administration’s drug price controls with leaders at last week’s Association for Accessible Medicines’ Access 2026 conference With all of the chatter on the Web, including in BR&R, on the policy and legislative actions that affect biosimilars, we were eager to hear from some very smart people on the direct-to-patient … Continue reading Deeper Views on TrumpRx (the Direct-to-Patient Channel), MFN and MFP, and Biosimilars →

Accord BioPharma received approval for Filkri, a filgrastim biosimilar, and Outlook Therapeutics journey to approval for its ONS-5010 continues after an FDA rejection. A Filkri Approval for Accord BioPharma In mid-February, Accord BioPharma announced that it had received FDA approval for Filkri (filgrastim-laha), making it the fifth filgrastim biosimilar to obtain approval (not counting Granix, … Continue reading A Filgrastim Biosimilar Approval, and a Bevacizumab Rejection →

National PBM reform does not address private labeling by PBMs and their subsidiaries directly, but it does imply that PBM private labels will not hold up over the long term. Since the announcement of the Federal Trade Commission (FTC) and Express Scripts (ESI) settlement, there has been some speculation regarding the effect of the settlement … Continue reading Will National PBM Reform Whither Away the Private-Label Channel? →

This guest commentary is written by Robert Goria, Chief Trade Strategy Officer, CarePartners Pharmacy. The article addresses a practical approach to navigating biosimilar substitution, as we may soon be seeing significant change in the meaning of interchangeability for biosimilars. The US biologics market is undergoing a quiet but consequential shift. Years after the Biologics Price … Continue reading Navigating Biosimilar Substitution →

Amgen’s Pavblu has been the most successful US biosimilar launch by any manufacturer to date, with more than $600 million in net sales in 2025. The February 3rd earnings report released by Amgen underscore the major success of its Pavblu launch, the first biosimilar competitor to Eylea. For the full year 2025, US net sales … Continue reading Update on Amgen’s Pavblu Launch Success →

TrumpRx unveiled the first 43 products listed as available through this direct-to-consumer (DTC) clearinghouse site, and one biosimilar is offered, at a discount of more than $300 per dose. Pfizer’s Abrilada is being offered through TrumpRx at a price of $207.60 per 40 mg/0.8 mL prefilled pen. The prefilled syringe version is $415.20 (for a … Continue reading The Biosimilar on TrumpRx: Pfizer Offering Further Discounts on Abrilada →

Perhaps the greatest effect of yesterday’s announced Federal Trade Commission (FTC) settlement with Express Scripts is its mandate on consumer exposure to net prices at the pharmacy counter as opposed to the inflated list prices of insulin products. But the implications go far beyond insulin. The settlement may contribute to the demise of high wholesale … Continue reading The FTC–ESI Settlement: Net Price Rules at the Pharmacy Counter →

The House of Representatives passed the long-awaited spending bill, and it was signed by President Trump on February 3rd. From the standpoint of health care, the bill failed to extend Affordable Care Act subsidies, but remarkably, major pharmacy benefit manager (PBM) reforms survived the final version. Meaningful PBM Reforms, Including Rebate Pass Throughs The Consolidated … Continue reading Significant PBM Reform Is Finally Achieved →

TrumpRx is a hot topic today, especially in the context of its foundational concept: direct-to-consumer (DTC) or direct-to-patient (DTP) drug purchase and dispensing. Apparently set to launch, after the Department of Health and Human Services (HHS) issued a guidance that Secretary Robert F. Kennedy, Jr, said,  “makes clear that manufacturers can offer lower-cost drugs directly … Continue reading What TrumpRx Is, What It Is not, and Concerns for Biosimilars →

Thirty-seven organizations representing manufacturers, health plans and insurers, pharmacy benefit managers, corporate employers, consumers, and patients have banded together to support and hopefully reinvigorate action to pass the bicameral Biosimilar Red Tape Elimination Act. The Biosimilar Red Tape Elimination Act has been long-awaited, but it is not making much progress through Congress. As of January … Continue reading An Injection of Support for the Biosimilar Red Tape Elimination Act →

On January 12, AbbVie announced that it had reached an agreement with the Trump administration on participation in its most favored nation (MFN) pricing initiative, and making certain medications available through its direct-to-consumer platform. With the various agreements made with 15 other pharmaceutical companies, specific drugs were not disclosed. This is the first time in … Continue reading AbbVie, MFN, and a World of Ambiguity →

For biosimilar industry watchers like BR&R, Samsung Bioepis has played a leading role in introducing biosimilars to the US market, first with its infliximab biosimilar Renflexis. Over the years, as their biosimilar candidates were approved by the FDA, the pipeline appeared to thin, with pembrolizumab (SB27) being the sole publicly disclosed biosimilar candidate, as of … Continue reading Samsung Bioepis Reinforces Its Biosimilar Pipeline →

Here’s a question that has been asked repeatedly over the last year or so: Does it make sense to have private label medical benefit-covered biosimilars? We’ve seen the spread of private-label or “white-label” biosimilars, by the big 3 pharmacy benefit managers (PBMs) specifically, for adalimumab and ustekinumab. Although we’re not sure of current market utilization … Continue reading Is There a Place for Private-Label Biosimilars Covered Under the Medical Benefit ? →

Do you get the feeling we’re being deluged with news from the federal government on health regulation? That’s because we are. On December 23, the Centers for Medicare and Medicaid Services (CMS) got into the act again, announcing two new major demonstration projects that seek to cut pharmaceutical costs. The Medicare Guarding US Medicare Against … Continue reading GLOBE, GUARD, and More MFN →

With this first post since the holidays, there is so much to discuss, yet so little firm ground on which to anchor the discussion. Since December 23, the Trump administration has added two more drug pricing reform models to the gordian knot of US pharmaceutical reimbursement, and authors from the University of Washington School of … Continue reading The Next Set of Biologics for Medicare Price Negotiations Predicted (and Eliminated?) →

A long-time member of a national health plan, Ms. Jones had been utilizing adalimumab biosimilar A for the past 18 months. It had been the preferred adalimumab product and thus is associated with the least out-of-pocket cost. On January 15, she opens her newly delivered medication, and finds a different biosimilar medication, with a different … Continue reading Avoiding Patient Disruption in Frequent Biosimilar Switching: A Focus on the Specialty Pharmacy →

FDA Releases Guidance on Biosimilar and Reference Product Promotion and Advertising Earlier this month, the FDA released its guidance on advertising and promotion of biosimilars and reference products, with questions and answers for industry. The guidance provides suggestions (not rules) by the FDA for the characterization of biosimilars and interchangeable products in promotional materials, including … Continue reading Biosimilar Bytes →

The numbers don’t lie: The first biosimilar foray into the aflibercept category is going very well for Amgen. The intravitreal injectable market has been a complicated, highly contested arena for many years. The first-generation products are VEGF inhibitors, and a second-generation product that targets both the VEGF and Ang-2 pathways (faricimab, reference product Vabysmo). The … Continue reading Amgen’s Pavblu Makes Significant Inroads into the Aflibercept Market →

India-based drug maker Lupin Ltd announced on December 1 that it has received approval from the FDA for its pegfilgrastim biosimilar Armlupeg (pegfilgrastim-unne). Armlupeg’s indications include: (1) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile … Continue reading Lupin Scores Its First FDA-Approved Biosimilar →

On October 30, we reported on the FDA’s decision to release a draft guidance that would obviate the need for late-stage, comparative efficacy studies for most biosimilar candidates. We brought up the question of timing, in that for some very high-profile biologic targets, phase 3 studies were already underway. The removal of a phase 3 … Continue reading Phase 3 Trials Already Being Reconsidered by Manufacturers for Keytruda and Opdivo Biosimilars →

On November 17, Tyruko (reference product, Tysabri) became available to treat relapsing forms of multiple sclerosis (MS), in addition to Crohn’s disease. This agent is the first biosimilar to treat MS in the United States. Manufactured by Polpharma Biologics and commercialized by Sandoz, Tyruko was approved by the FDA in August 2023, but its launch … Continue reading Sandoz Announces the Launch of Tyruko, the First Biosimilar for the Treatment of Multiple Sclerosis →

On November 17, Organon and its China-based partner Henlius announced that the FDA has approved the first pertuzumab biosimilar. The Perjeta biosimilar was dubbed Poherdy (pertuzumab-dpzb). Poherdy is approved for use for all of the indications of the reference product Perjeta (manufacturer, Roche). Pertuzumab is an HER2/neu-receptor agonist that is used in combination with trastuzumab … Continue reading First Pertuzumab Biosimilar Approved by the FDA: Poherdy by Henlius and Organon →

The level of price discounting for Stelara biosimilars has hit a new low (or high), depending on your point of view. Hikma Pharmaceuticals USA announced on November 6 that it has launched Starjemza, its ustekinumab biosimilar, manufactured by Bio-Thera Solutions. Yesterday, Mark Cuban’s Cost Plus Drug Company announced the availability of Starjemza’s low monthly price … Continue reading Mark Cuban’s 99% Discount on Ustekinumab Biosimilar →

Any biosimilar manufacturer will tell you that one of the most daunting and delaying issues in biosimilar development is the abuse of the patent system by reference manufacturers. They delay launch by years, resulting in billions in additional revenues for the reference product, and extra workload for the courts. At last week’s GRx+Biosims meeting, panelists … Continue reading The Sad State of Patent Affairs: Legislative Help on the Way? →

At the Association for Accessible Medicines’ GRx+Biosims meeting on Wednesday, we heard hints of a major announcement regarding biosimilar 351(k) application requirements. By the time FDA Commissioner Marty Makary, MD, MPH, left the stage, we knew that a new draft guidance would be announced in an HHS press conference that afternoon. Indeed, HHS Secretary Robert … Continue reading The Demise of the Comparative Efficacy Trial Requirement for Biosimilars →

The Kaiser Family Foundation recently released its latest annual report on employer-sponsored health care benefit costs. People seem to be aghast that the premium (employer plus worker contributions) for a family health insurance policy is $26,993. As KFF’s CEO Drew Altman stated, “You can buy a new Toyota Corolla Hybrid every year for less than … Continue reading Rising Health Costs, Care Affordability, and Biosimilars →

More than 2 years since the approval of the natalizumab biosimilar (reference product, Tysabri), partners Sandoz and Polpharma Biologics have yet to introduce neurologists to the concept of biosimilar prescribing. The reason is a JC virus test submitted by the biosimilar manufacturers, which is required for patients prior to receiving natalizumab treatment, has not yet … Continue reading The Early Outlook for Ocrelizumab Biosimilars →

In an expansion on their previously announced alliance, Biocon Biologics will begin manufacturing a private-label version of insulin glargine for Civica, which Civica will then commercialize in the US. Biocon will continue to market its own brand of insulin glargine biosimilar (Semglee/insulin glargine-yfgn). Civica is a nonprofit pharmaceutical company, that was founded to expand access … Continue reading Biocon Will Produce an Insulin Glargine Biosimilar for Civica →

Enoby and Xtrenbo are the latest denosumab biosimilars to receive FDA approval, referencing Prolia and Xgeva, respectively. The approval, announced October 14, is the seventh denosumab biosimilar. Both are designated denosumab-qbde. Enoby is approved to treat the principal osteoporosis-related indications of Prolia, and Xtrenbo’s approval matches the oncology-related skeletal indications of Xgeva. Gedeon Richter’s partner … Continue reading Gedeon Richter and Hikma Receive FDA Biosimilar Approval for Denosumab →

On October 9, Celltrion, Inc. announced it had received the nod from the FDA on the latest aflibercept biosimilar, Eydenzelt (aflibercept-boav). This Eylea biosimilar is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Celltrion will join a heavily competitive field when it does … Continue reading Celltrion Receives FDA Approval for Its Aflibercept Biosimilar →

Enbrel is an extreme example of unintended marketing exclusivity (30 years), a result of our flawed drug patent system. The implementation of the negotiated maximum fair price (MFP) in January 2026 for the Medicare population will at least be a tentative step to obtaining better value for this individual biologic. We reported back in August … Continue reading Does the Colorado Decision on Enbrel Represent a New Threat to Biosimilar Development? →

Seeking to become the second omalizumab biosimilar to be approved in the US, Amneal Biosciences and Kashiv BioSciences announced on September 26 that they had filed a biologic licensing application for the approval of their biosimilar candidate ADL-018. “The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents … Continue reading Partners Amneal and Kashiv File 351(k) Application for Omalizumab Biosimilar →

Remember Leslie Nielsen’s character, Officer Frank Drebin, in the first Naked Gun movie, admonishing bystanders who were watching a catastrophe of explosions behind him, “Nothing to see here, folks. Please disperse. Nothing to see here”? Well, with biosimilar clinical trial results, there really hasn’t been anything new to see here. In the early days of … Continue reading How Newsworthy Are Biosimilar Clinical Trials Today? →

The Trump administration’s recent crackdown on direct-to-consumer (DTC) drug advertising got me thinking. I’m of an age where the shows I watch on television or stream are rife with DTC advertising for diabetes drugs and biologics to treat autoimmune disease, rare disease, macular degeneration, and other ophthalmologic disorders. I was never a fan of DTC … Continue reading DTC Advertising and the Biosimilar Opportunity →

Ustekinumab biosimilars are many and largely sold at big discounts relative to the reference product Stelara. The major PBMs are beginning to publish formularies for 2026. For instance, Express Scripts will have two biosimilars on formulary—Biocon Biologic’s Yesintek and Alvotech/Teva’s Selarsdi (at 90% and 85%, respectively, off the wholesale acquisition cost [WAC] of Stelara) in … Continue reading Fewer Stelara Biosimilar Makers Are Offering High-WAC Pricing →

Sandoz Clears a Patent Hurdle With Regeneron on Aflibercept Biosimilar On September 9th, Sandoz announced that it had reached an agreement with the patent holder of the reference product Eylea, clearing its way for a launch towards the end of 2026. The agreement with Regeneron halts all patent infringement proceedings against the biosimilar manufacturer. Regeneron … Continue reading Biosimilar Bytes: Sandoz’s Agreement and Organon/Henlius’ Approval →

From our experience with the adalimumab biosimilar launches in 2023, we learned several lessons. One is that our existing pharmacy benefit manager (PBM)–driven rebate system dictates not only coverage but utilization. Second is that employers must flex their leverage muscle if they want full pass-through of rebates and full transparency regarding PBM-based rebates and fees. … Continue reading Employer Survey Sees Further Demand for PBM Transparency →

On September 5th, the FDA released 89 new complete response letters (CRLs) that had been sent to pharmaceutical manufacturers in 2024 and 2025. The release of these letters, indicating that the FDA cannot approve the drug maker’s product at the present time, were part of the agency’s transparency initiative that we reported on in July. … Continue reading The Latest Biosimilar-Related Complete Response Letters Released by FDA →

Just as a reminder, Medicare’s negotiated price for Stelara is $4,695 per 30-day supply. That is a 66% discount from the wholesale acquisition cost (WAC). The current discount for biosimilar ustekinumab is 85% to 92%, yielding prices of $1500–$2,300 per month. Johnson and Johnson, Stelara’s manufacturer, wishes its lowest net price was $4,700 per month! … Continue reading Biosimilar Savings for Stelara Make Medicare’s Negotiated Price Seem Like a Bad Deal; Don’t Expect Biosimilar Savings on Enbrel →

Amidst the Trump administration’s efforts to reduce FDA and Health and Human Services Department staffing, there was concern regarding the agency’s ability to maintain its published schedule for approvals and biosimilar licensing application processing. There was hope the industry would be spared the effects of the administration’s cutbacks, because the program is largely self-funded: The … Continue reading Some Biosimilar User Fees Are Dropping for Fiscal Year 2026 →

Alvotech has announced a new marketing agreement for its biosimilar of Cimzia, which applies to commercialization in Europe. The company has extended its marketing relationship with Advanz Pharma to include AVT10 in Europe. The US marketing of AVT10 (formally known as XB003) is still an open question. As reported in 2020, biosimilar manufacturers have in … Continue reading A Cimzia Biosimilar Update, and Another Ustekinumab Price Cut →

In our previous post, we explained that ustekinumab biosimilar pricing discounts of up to 90% still resulted in net prices of $3,000 or more per month. On August 18th, Accord Biopharma announced that it has launched its Imuldosa brand of ustekinumab biosimilar at a 92% wholesale acquisition cost (WAC) discount relative to Stelara. This bests … Continue reading Raising the Bar on Lower WAC Prices for Ustekinumab Biosimilars →

Whereas the biosimilar industry is under intense pressure from competition, government policies, and slow adoption in certain disease states, there is one area that I think is somewhat more positive: profitability at the present ustekinumab biosimilar discounted pricing. When the adalimumab market opened in January of 2023 discounts off list price increased at a rate … Continue reading Can Biosimilars Survive on These Low WAC Discounts? Remember, not all WACs Are the Same →

On July 14, 2025, a new whitepaper sponsored by the Association for Accessible Medicines was released. “The Long-Term Effects of Medicare Price Negotiations on Drug Competition” was written by Alex Brill and Christy Robinson at Matrix Global Advisors. It examines the potential long-term impact that the federal government’s role as a price setter could have … Continue reading A Conversation with Alex M. Brill, CEO, Matrix Global Advisors →

Biosimilars have never been assured market success. The first oncology and oncology support therapies that were approved as biosimilars gained fairly rapid adoption, however, despite price points that were not always deeply discounted relative to the reference product. With the publication of Samsung Bioepis’ latest Biosimilar Market Report, covering data through the first quarter of … Continue reading Which Biosimilar Brands Are Struggling to Survive? →

Biocon Biologics announced last week that they received FDA approval for a new biosimilar version of insulin aspart which they have dubbed Kirsty (insulin aspart-xjhz). The FDA has granted Biocon Biologics the interchangeability designation for automatic substitution with the reference product NovoLog. Biocon Biologics first applied for approval of this product in July 2020. The … Continue reading After Five-Year Journey, Biocon Biologics Obtains a New Approval for Insulin Aspart Biosimilar →

With Biogen’s decision to exit the US biosimilar market, Samsung Bioepis had to find a new marketing partner for its biosimilar ophthalmology portfolio. On July 17th, the company announced that its search for a replacement was over: It had entered a new license, development, and commercialization agreement with Harrow. Harrow will assume marketing responsibilities for … Continue reading Samsung Bioepis Finds New Commercial Partner for Its Ophthalmology Biosimilars →

The FDA released today a database of complete response letters (CRLs) sent to manufacturers of small molecule and biologic drug candidates that were eventually approved for marketing in the US between 2020 and 2024. This transparency opens a window to  information that is not always publicized by the sponsoring manufacturer. Sometimes, CRLs are announced by … Continue reading Database of FDA Rejection Letters Adds Transparency to Biosimilar Development →

Fresenius Kabi announced July 1 that it has launched its denosumab biosimilars Conexxence and Bomyntra (denosumab-bnht), making it the second biosimilar available in this highly competitive drug category. The drug was approved by the FDA in March 2025.   The denosumab biosimilars expand Fresenius Kabi’s portfolio of marketed biosimilars to 4 drug categories (including pegfilgrastim, … Continue reading Fresenius Kabi Launches the Second Denosumab Biosimilar: Conexxence and Bomyntra, Other Denosumab Launches Pending  →

In preparation for anticipated 2026 launches in the US for an omalizumab biosimilar, we are monitoring the developments of some of the leading candidates. Top-line, preliminary phase 3 results were released June 25 by partners Amneal Pharmaceuticals and Kashiv Biosciences for ADL-018, their progressing omalizumab biosimilar. In their double-blinded, randomized clinical efficacy and safety trial … Continue reading Amneal and Kashiv Announce Progress in Development of Omalizumab Biosimilar →

Personally, I try to pay as little attention as possible to the administration’s current, contradictory federal pronouncements on tariffs. But in terms of biosimilars (and generics), that is not truly possible. If high tariffs on certain countries are implemented, the damage to a biosimilar industry facing several existential challenges today can be easy to grasp … Continue reading Tariff Policy and Biosimilars: Dancing Around Another Threat to the Industry →

Utilizing Alvotech/Teva’s ustekinumab biosimilar, Navitus Health will begin offering its Lumicera Health-branded ustekinumab-aekn, beginning July 1, while excluding the reference product Stelara. The net price of this product is said to be approximately $1,000 per 90-mg dose, or more than a 90% discount from Stelara’s wholesale acquisition cost (WAC). Like the big 3 PBMs with … Continue reading Navitus Private-Label Ustekinumab Available July 1 →

For decades, the stated purpose of prior authorization (PA) for managed health care plans has been as follows: to ensure the appropriateness of a specific drug for any specific patient. The Academy of Managed Care Pharmacy states, “[PA] is an essential tool that is used to ensure that drug benefits are administered as designed and … Continue reading Improving Prior Authorization Processes: An Obstinate Goal for an Essential Payer Tool →

Several biosimilar news items are of note this week, including an official move by our northern neighbor to streamline its biosimilar clinical trial requirements, a new collaboration between biosimilar makers on a Keytruda biosimilar, and a new FDA approval broadening the pediatric indications for one ustekinumab biosimilar product. Health Canada’s Draft Guidance: Phase 3 Trials … Continue reading Biosimilar Bytes →

For those who have a feeling of déjà vu (“all over again”, per Yogi Berra), the recently reintroduced Biosimilar Red Tape Elimination Act into the Senate is yet another attempt to improve the interchangeability conversation. That is, to take the term out of the conversation altogether. Senate Bill 1954 was introduced June 4 by Senator … Continue reading Is the Third Time the Charm? The Biosimilar Red Tape Elimination Act Is Reintroduced in the Senate →

Accumulating evidence points to physicians’ growing comfort with prescribing biosimilars. A newly published study from the Journal of Managed Care and Specialty Pharmacy, based on a 2023 survey, found that physicians treating immunologic disorders were “likely” or “very likely” to prescribe a biosimilar for a new start patient as well as to recommend biosimilars for … Continue reading With Experience and Coverage, Physician Comfort With Immunology Biosimilars Increases →

On June 2, 2025, Sandoz announced the launch of its Wyost/Jubbonti denosumab biosimilar, the first of this drug category to be marketed. In a press release, Keren Haruvi, President, Sandoz North America, stated, “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps … Continue reading The First Denosumab Biosimilar Reaches the US Market →

The Food and Drug Administration has issued new interchangeability designations for at least two adalimumab biosimilars in recent days, which ends exclusivity for Alvotech and Teva’s Simlandi for the most-commonly prescribed dose. Last week, Celltrion announced receiving their designation for Yuflyma, and today, Samsung Bioepis and Organon released a press statement indicating that Hadlima was … Continue reading New Adalimumab Interchangeability Designations Announced, Creating a Complex, Confusing Environment →

Today, the Department of Health and Human Services released further detail on its most favored nation (MFN) pricing proposal for pharmaceuticals sold in the US. According to the press release issued by the department the target price will be lowest price in a country (that is, a member of the Organization for Economic Cooperation and … Continue reading The Trump Most Favored Nation Pricing Proposal: Bad News for Biosimilars →

I’ve resisted commenting on the rapid-fire news reports announced over the last couple of weeks affecting the pharmaceutical industry. Based on the past, who knows which initiative, if any, will be implemented or withdrawn? And do we really know what will develop tomorrow, or the next day, in terms of drug pricing and PBM reform? … Continue reading Chaos vs. Control →

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. It has been several years since a newer player has entered the … Continue reading A Profile of a Lesser-Known Player in the Biosimilar Space: Meitheal Pharmaceuticals →

For years, reference drug manufacturers have tried to extend the exclusivity periods for their products with patent mazes, lifecycle management tools, and long legal battles resulting in marketing settlements. Etanercept has been the poster child for inexplicable delays in biosimilar competition in the US. With a potential launch date of 2029, Enbrel will have had … Continue reading Better Late Than Never? Sandoz Files Antitrust Lawsuit to Enable Launch of Etanercept Biosimilar →

In the conclusion of our reporting from the Festival of Biologics USA meeting last week, we covered present effects on the upcoming biosimilar pipeline as well as the area of biosimilar delivery device testing and regulation. DIFFICULT DECISIONS AHEAD ON THE BIOSIMILAR PIPELINE Michael Sarshad, Managing Director, Syneos Health Consulting, believes that there are many … Continue reading Biosimilars at the Festival of Biologics: Part 2: Biosimilar Pipeline and Delivery Devices →

The Festival of Biologics USA meeting wrapped up last Thursday, and the emphasis was all about biosimilar sustainability, and the various factors threatening it. These included not only challenges but the opportunities that will be lost should we continue on our present path. In this post, I report on some of the most salient sessions, … Continue reading Biosimilar Topics at the Festival of Biologics: Part 1: Savings, Retinal Specialist Education, and Falling ASPs →

It’s been a busy couple of weeks, and we’re taking this time to catch up on some specific biosimilar product news. Samsung Bioepis and Teva Launches Their Eculizumab Biosimilar The biosimilar maker Samsung Bioepis and its marketing partner Teva Pharmaceuticals announced on April 7 that it had launched Epysqli in the United States. This is … Continue reading Biosimilar Bytes: Eculizumab Biosimilar Launches, Rights to Actemra Biosimilar Sold, and New Biosimilar Bevacizumab Approved →

On Tuesday April 8th the House Subcommittee on Health (of the Ways and Means Committee) held a hearing on lowering costs for patients and the health of the biosimilar market. The testimony of several experts in the biologics and biosimilar areas supported the need to recalibrate PBMs’ relationship to the biosimilar market as well as … Continue reading Biosimilar Hearings Day in Congress →

At the Academy of Managed Care Pharmacy (AMCP) annual meeting last week, several posters bolstered existing real-world evidence that biosimilar adalimumab was associated with similar outcomes to those of Humira, and that may translate into the absence of any significant nocebo effect. Only 2% Switched Back to Humira Researchers from Employers Health, Columbus, Ohio,1 evaluated … Continue reading Good Outcomes, Little Nocebo Effect With Adalimumab Biosimilars →

Does Anyone Really Know What Price It Is? It should be no surprise that Quallent Pharmaceuticals, the specialty distributor subsidiary of Evernorth, has decided to offer their private-label version of ustekinumab at neither a high nor a low wholesale acquisition cost (WAC). The private-label drug, which is based on Samsung Bioepis’ product, is being sold … Continue reading Quallent’s Questionable Ustekinumab Biosimilar Pricing, and Enbrel Price Ceiling in the Rockies →

The release of the Center for Medicare and Medicaid Services (CMS) average sales price (ASP) figures for the second quarter revealed a startling and dangerous trend for ranibizumab products: up to a 50% drop in pricing from the first quarter of 2025. As previously reported, Formycon AG’s marketing partner Sandoz has decided to take the … Continue reading The Implications of the Freefall in Ranibizumab ASPs →

With the interchangeability designation being an ineffective tool in shifting prescriptions from the reference product to a biosimilar, Sandoz has taken a page out of a health plan’s playbook: Going directly to patients, offering them a cash incentive for moving to a biosimilar. Called the Hyrimoz Patient Transition program, Sandoz offers patients a single $200 … Continue reading Sandoz: Patients Get a $200 Debit Card to Switch to Hyrimoz →

The aflibercept biosimilar Pavblu has been marketed by Amgen since October 2024, after a District Court denied Regeneron’s motion for a preliminary injunction against the biosimilar maker. A Court of Appeals decided last week that Regeneron’s patent violation argument was not persuasive, validating Amgen’s decision to launch Pavblu at-risk. Amgen’s at-risk launch of Pavblu yielded … Continue reading Amgen’s At-Risk Launch of Pavblu Bolstered by Court Decision →

On March 10, Celltrion announced receiving US marketing authorization from the FDA for its omalizumab biosimilar Omlyclo (omalizumab-igec). This is the first omalizumab biosimilar (reference product, Xolair) to receive US approval. The FDA also granted Celltrion the interchangeability designation for Omlyclo. Omalizumab is an anti-IgE antibody.   The approval was for all of the reference … Continue reading Celltrion Gains First Omalizumab Biosimilar Approval →

Biocon Biologics has announced a new agreement with Civica Inc., “to expand patient access and affordability to insulin aspart in the US.” India-based Biocon Biologics does not currently have an approved insulin aspart biosimilar in the US, but it is approved in Canada. The company is pursuing its own insulin aspart biosimilar in the US, … Continue reading Biocon Biologics Agrees to Supply Civica With Materials to Bring Another Biosimilar Insulin Aspart to Market →

On March 3, Celltrion announced that the FDA has approved the company’s denosumab biosimilars Stoboclo (reference product, Prolia) and Osenvelt (reference product Xgeva). The nonproprietary designation for both molecules is denosumab-bmwo. The approval covers all indications of the reference products, including osteoporosis with high risk of fracture in men and postmenopausal women, glucocorticoid-induced osteoporosis, increasing … Continue reading FDA Approves Celltrion’s Denosumab Biosimilars, to Launch in June →

Yesterday, it was announced that Johnson and Johnson (J&J) had sought a preliminary injunction against Samsung Bioepis to prevent sales of a planned private-label version of Pyzchiva with an undisclosed pharmacy benefit manager (PBM). J&J claimed that the licensing arrangement signed in 2023 with Samsung did not permit sublicensing, as it was referred to in … Continue reading What the J&J Suit Against Samsung Bioepis Tells Us →

Following Amgen’s January launch of its Stelara biosimilar (Wezlana), at least five other ustekinumab biosimilars have stepped up to the plate, with a licensing dates of February 21 to March 7. Biocon Biologics announced that Yesintek is now available for prescription. Partners Samsung Bioepis and Sandoz launched Pyzchiva. Alvotech and Teva launched Selarsdi on February … Continue reading A New Wave of Ustekinumab Biosimilar Launches, Discounted up to 90% →

Although Cimerli had captured the highest utilization in the ranibizumab category, its continued availability in the US seems precarious. A press release by Formycon AG, part owner of the biosimilar’s developer (Bioeq), stated last week that ”Due to the increasing price discounts among ranibizumab providers in the US, Bioeq AG, the exclusive license holder of … Continue reading Availability of Top Ranibizumab Biosimilar May be Paused →

Sanofi-Aventis, the makers of the insulin glargine reference product Lantus, has jumped into the biosimilar arena, having received FDA approval on February 14 for an insulin aspart biosimilar. Dubbed Merilog (insulin aspart-szjj), the agent is a rapid-acting insulin whose reference drug is NovoLog. There are two biosimilars to insulin glargine, the long-acting formulation, and this … Continue reading First Insulin Aspart Biosimilar Approved: Sanofi’s Merilog →

By F. Randy Vogenberg, PhD Dr. Vogenberg is Principal, Institute for Integrated Healthcare, and Board Leader, Employer Provider Council, Greenville, SC Employers can wield tremendous leverage in optimizing biosimilar uptake, but they have remained relatively disengaged to date. The successful record of biosimilar competition lowering biologic drug costs can be far better supported by self-insured … Continue reading Employer Plans, Private-Label Biosimilars, Little Transparency →

On February 16, the FDA approved Samsung Bioepis’ biologics license application for SB16, its denosumab biosimilar candidate. Dubbed Ospomyv for the treatment of postmenopausal women with osteoporosis (reference product Prolia), and Xbryk (denosumab-dssb) for the treatment of bone complications of oncology disorders (reference product Xgeva), this is the second denosumab biosimilar approval in the US. … Continue reading Samsung Bioepis Gets FDA Approval for Its Denosumab Biosimilar →

In part 2 and the conclusion of our reporting on last week’s Access 2025 meeting, we cover the effect of the new private-label channel in the biosimilar marketplace, implications for the FDA of the Department of Government Efficiency (DOGE)’s early retirement initiative, and other Trump administration actions.    Private Labeling as a Mechanism for Better … Continue reading More Biosimilar Discussions at Access 2025: Private Labeling and New Trump Administration Actions →

The bulk of the discussion at this year’s ACCESS 2025 conference fell into four buckets: (1) the effect of the Trump administration’s tariffs on the active pharmaceutical ingredient (API) supply chain, (2) the magnitude of the potential lost opportunity for biosimilars that are not developed (or the “biosimilar void”), (3) the effect of the Department … Continue reading Addressing Rapidly Changing Biosimilar Dynamics at Access 2025 →

On January 30, the FDA approved Avtozma (tocilizumab-anoh), which was formerly known as CT-P47 by Celltrion. Celltrion will market Avtozma as both intravenous and subcutaneous formulations, in the same dosages as the reference product Actemra. Avtozma received approval for the following indications: Actemra has only one indication that Avtozma does not: cytokine-release syndrome related to … Continue reading Celltrion’s Avtozma Approved by the FDA: Now There Are Three →

Partners Alvotech and Teva announced that the FDA has accepted their 351(k) application for AVT05, a biosimilar candidate to compete with the reference product Simponi. Golimumab is a TNF-alpha inhibiting antibody, and the reference manufacturer is Johnson & Johnson. This first golimumab biosimilar drug application covers both the standard Simponi and Simponi Aria forms, which … Continue reading First Golimumab Biosimilar Application Accepted by FDA →

WARNING: This is a very different post than I have published, but it is a pointed, gut reaction to the blizzard of executive actions, announcements, and directions of the new presidential administration. Comments and feedback are always welcome. We’ve lived through chaotic week 1 of the new presidential administration, we’ve seen new and escalating turmoil … Continue reading Some Random Thoughts on a Rambling, Bizarre First Seven Days →

Since the first approval of Fulphila in 2018, the pegfilgrastim market has added competitors and steadily decreased in net price through 2022. The latest Samsung Bioepis Biosimilar Market Report indicates that pegfilgrastim biosimilar marketshare is up to 85% in year 7. And two products account for 73% of that total. The picture has changed considerably … Continue reading Why the Distortion in the Pegfilgrastim Market? →

A new study tags the prevalence of autoimmune diseases at 4.6%, or around 15.2 million people in the US. More than 34% have at least one autoimmune disease and 8% have three autoimmune diseases. Using data from electronic health records, they calculated prevalence figures for dozens of autoimmune disorders. Some of the most notable prevalence … Continue reading A Different Perspective on Biosimilar Cost Savings →

On January 10, Samsung Bioepis announced a new arrangement with Teva to commercialize the former’s eculizumab biosimilar Epysqli (reference product, Soliris) in the US. In a press release, Kyung-Ah Kim, the recently promoted President and CEO of Samsung Bioepis, stated “We are excited to announce this new strategic partnership for a biosimilar which has a … Continue reading Samsung Bioepis and Teva Ink a Deal for Epysqli; Tanvex Gets a Thumbs Down →

The onset of the new year brings with it the first major event in 2025: The launch of the first ustekinumab biosimilar (reference product, Stelara). However, several important developments will be worth watching over the next 12 months. Here are some of the most notable, including several ustekinumab biosimilar launches: Ustekinumab: The Second Pharmacy Benefit–Covered … Continue reading What’s Next for Biosimilars in 2025? →

In the early days of biosimilar utilization, the nocebo effect was a clear worry of the biosimilar industry. When patients knew they were receiving a biosimilar rather than a reference product, discontinuation rates and adverse drug events were noticeably higher. On an absolute basis, nocebo rates are not alarmingly high; a 2018 study found reported … Continue reading Mitigating the Biosimilar Nocebo Effect →

In some cases, the only time a company reveals important developments is during their quarterly earnings calls. This past “earnings season” also yielded a few interesting tidbits. The first notes relate to the adalimumab market, as reported by the manufacturers. First, AbbVie disclosed that third-quarter net sales of Humira in the US were down 42% … Continue reading Third-Quarter Earnings News and Biosimilar Revenues →

In a final gesture that closes the books on its attempt to become a “pure-play” biosimilar company, Coherus Biosciences has sold off its pegfilgrastim franchise–its last biosimilar asset–to Intas Pharmaceuticals for $558 million. The move comes as somewhat of a surprise, in that much of the company’s hopes were staked on the revenues to be … Continue reading Coherus Waves Bye Bye to Biosimilars →

On December 2, Biocon Biologics announced that it had received FDA approval for Yesintek (ustekinumab-kfce), the sixth authorized biosimilar to Stelara (so far). The Yesintek approval assures Biocon Biologics that it will be able to launch its latest biosimilar in the middle of the pack, along with Fresenius Kabi, Samsung Bioepis, and Sandoz, no later … Continue reading Biocon Biologics Joins the Ustekinumab Fray With Yesintek →

Are private-labeled biosimilars from PBM distributors a lifeline for the biosimilar industry or another barrier to ensuring biosimilar competition into the future? In 2023, adalimumab biosimilars gained virtually no traction when covered at parity with the reference product Humira®. Only once CVS Health launched its Cordavis distributor subsidiary in April 2024 did adalimumab biosimilar uptake … Continue reading PBM Private Labeling: A Boon or Bane to Biosimilar Drug Makers? →

Employers are seemingly worried as hell about their health care costs, and they’re not willing to take it anymore. That seems to be the message of a new purchaser survey by the National Alliance of Healthcare Purchasing Coalitions. The National Alliance surveyed employers in the fall of 2024 and published the results on October 29, … Continue reading Employers Questioning Their PBMs Over Conflict of Interest, Biosimilars, and Transparency →

A couple of significant 351(k) applications were accepted by the Food and Drug Administration in the month of October for denosumab biosimilars. Teva announced that its applications for denosumab candidate TVB-009P were accepted by the European Medicines Agency as well as the FDA in early October. The application included data from a phase 3 trial … Continue reading New Denosumab Applications Filed, New Ustekinumab Biosimilar Approved →

At October’s GRx+Biosims meeting, we sat down with Joshua Salsi to discuss how a company like Biocon Biologics is facing the rapidly evolving regulatory and biosimilar market access environment. The conversation involved the difficulties in making strategic decisions about molecules that may launch many years in the future, as well as the sustainability of the … Continue reading A Conversation with Joshua Salsi, Head of North America, Biocon Biologics →

On October 22, the federal appeals court denied Regeneron’s request for an injunction against Amgen pending appeal, which would have forestalled the biosimilar maker’s launch of Pavblu®, its biosimilar version of Eylea® (aflibercept). In late September, a judge from the District Court for the Northern Virginia District of West Virginia refused Regeneron’s original request for … Continue reading Amgen Wins Injunction Battle Against Regeneron, Paving Way for Aflibercept Launch →

As the Food and Drug Administration (FDA) begins to deemphasize the interchangeability designation, with an eye towards making any approved biosimilar interchangeable with the reference product, an expert panel at this week’s GRx+Biosims 2024 conference tackled the prevailing issue: Does interchangeability matter today? One major detail underlying this discussion was not specifically mentioned: An interchangeability … Continue reading Practically Speaking, Does Biosimilar Interchangeability Matter Today? →

The fourth ustekinumab biosimilar to receive FDA approval is Otulfi™, which was developed by Formycon AG and will be marketed by its partner Fresenius Kabi. Originally designated FYB202, the biosimilar’s nonproprietary name is ustekinumab-aauz. It is Fresenius Kabi’s fourth biosimilar approval in the US. The FDA approval was based on the totality of evidence, including … Continue reading Partners Fresenius Kabi and Formycon Get FDA Approval for Their Ustekinumab Biosimilar →

In August 2023, CVS Health announced that it would begin offering several adalimumab biosimilars at a low wholesale acquisition cost (WAC) through the CVS Caremark commercial template formularies. This would also include a low-WAC adalimumab product from its subsidiary Cordavis. The program was instituted in April 2024, while also excluding branded Humira® from coverage. The strategy … Continue reading A Conversation With Joshua Fredell, PharmD, Vice President, PBM & Specialty Product Development, CVS Health →

Warning! This post veers away (eventually) from our focus on biosimilars. However, discussions about the Inflation Reduction Act (IRA)’s intended and unintended consequences are so prevalent, allow me to address one important point. This regards the area of pharmaceutical innovation. As inexact copies of complex biologic molecules, biosimilars would not be considered particularly innovative. The … Continue reading The IRA and Big Pharma: Is It a Real Threat to Drug Innovation? →

The Federal Trade Commission (FTC) has amplified its public presence over the past couple of months. In July, the FTC released a report on practices of pharmacy benefit managers (PBMs), which I myself thought to be of little value. It seemed to be nothing more than a basic explanation of the PBM model, specifically the … Continue reading The FTC Taking More Public Action on the PBM Rebate Front →

The last of the big 3 PBMs, which control upwards of 80% of US pharmacy benefit spending, has yielded to the competition. OptumRx will exclude Humira from some of its drug formulary offerings as of January 1, 2025. According to OptumRx, “Optum Rx will exclude Humira and prefer FDA-approved adalimumab biosimilars effective January 1, 2025 … Continue reading The Last Domino Falls: OptumRx to Exclude Humira® From Some Drug Formularies Beginning January 2025 →

On September 5, Evernorth announced that it was applying its newly implemented policy on adalimumab biosimilars to the 2025 launch of ustekinumab biosimilars as well. Effective in early 2025, patients will be eligible to receive an interchangeable ustekinumab biosimilar without any cost sharing, through its Accredo specialty pharmacy. Evernorth stated in its press release that … Continue reading Evernorth Extends Its Biosimilar Strategy With Ustekinumab Launch: Zero Copays and Private Labeling →

The newest IQVIA report reminds us of the strength of the oncology biosimilars bevacizumab, rituximab, and trastuzumab. Not only are these oncology biosimilars thriving, payers are making it increasingly difficult to obtain treatment with the innovator products when oncology biosimilars like these are available. The number of formulary exclusions nationally for all oncology products is … Continue reading IQVIA Confirms the Staying Power of Biosimilars in the Oncology Market →

In late April, Evernorth announced that its health plan Cigna and pharmacy benefit manager (PBM) Express Scripts would add coverage June 1 for the adalimumab biosimilars Cyltezo® by Boehringer Ingelheim and Simlandi® by Alvotech/Teva. On August 23, Evernorth took things a step further, announcing that it will exclude Humira® from its largest commercial formularies for … Continue reading Express Scripts Becomes Second PBM to Exclude Humira From Specific Drug Formularies →

The Inflation Reduction Act (IRA) mandated that the federal government begin to negotiate prices for high-impact medications on behalf of its Medicare beneficiaries. On August 15, the Centers for Medicare and Medicaid Services (CMS) announced the negotiated prices for the first 10 medications on its target list. The discounted prices will go into effect in … Continue reading The IRA Price Negotiation Discussion for Enbrel® and Stelara® Biosimilars →

On August 12, Sandoz announced that it had received FDA approval for its latest biosimilar: Enzeevu (aflibercept-abzu). This FDA approval includes the indication for wet age-related macular degeneration (or neovascular AMD [nAMD]). In Sandoz’s press release, Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said, “nAMD, or wet AMD, continues to be a leading cause of vision … Continue reading Enzeevu™ Joins Sandoz’s Ophthalmologic Biosimilar Franchise →

AbbVie stated that its net revenues (after discounts and rebates) for its adalimumab brand Humira® was $18.6 billion in 2022. The first adalimumab biosimilar was launched in January 2023, and the majority of the pack launched in July 2023. After 18 months of biosimilar availability in the drug class, utilization of adalimumab biosimilars has only … Continue reading 18 Months of US Adalimumab Biosimilar Competition Yields $11 Billion in Savings →

As of July 22, the FDA has approved 57 biosimilars for 17 reference biologics. It has been a decade since Sandoz filed its 351(k) application to become the first biosimilar marketed in the US. It seems like ages ago. Filed for approval on May 8, 2024, Zarxio® (filgrastim-sndz) was approved by the FDA on March … Continue reading A 10-Year Anniversary Assessment of FDA Biosimilar Approvals: Using the EMA as the Comparator →

On July 22, Samsung Bioepis announced that it has received marketing approval by the FDA for its eculizumab biosimilar Epysqli®. The vowel-challenged brand name, which also has an interesting nonproprietary suffix (eculizumab-aagh), is the second approved biosimilar for the reference product Solaris®. The approval for this C5 complement protein inhibitor covers the following indications: Samsung … Continue reading Samsung Bioepis’ Epysqli Is the Second Eculizumab Biosimilar Approved by the FDA →

The arguments in favor of streamlining biosimilar development are many, and support for it is broad, including regulators, biosimilar makers (of course), scientists, and other stakeholders. We’ve published several posts since 2021 on the need to reduce or eliminate the reliance on comparative clinical trials for biosimilar approval. See the following for a sample: Well, … Continue reading Compelling Arguments for Streamlining Biosimilar Development →

On July 11, the Senate voted to approve legislation that will limit the ability of pharmaceutical companies’ patent thickets to slow biosimilar competition. The outlook for this legislation, called the Affordable Prescriptions for Patients Act (Senate Bill 150), is by no means assured. Patent thickets have been a bane of biosimilar manufacturers from the implementation … Continue reading Bill to Limit Patent Thickets Passes Senate, Goes to House →

The recent Supreme Court decision striking down its 1984 ruling in Chevron v. Natural Resources Defense Council, has created a sizzling discussion on social media and news outlets. It has sent the healthcare sector reeling with potential implications. The summary issue in the Loper Bright Enterprises vs. Raimondo ruling, which struck down the so-called Chevron … Continue reading The Supreme Court and the Confusion It Has Sown →

The Federal Trade Commission (FTC) released its interim report on pharmacy benefit managers (PBMs). It was a treatise on how the PBMs are now wound, like poison ivy, around the trunk and boughs of the 300-foot healthcare tree. It coalesced intelligence about the PBM industry. It didn’t address ways to deal with the strangulating vine. … Continue reading The FTC Interim Report on PBMs: Prepare to Be Frustrated →

One of the more confusing situations in the world of the biosimilar pipeline was the status of Kashiv BioScience’s omalizumab biosimilar candidate. On July 2, the company announced that Amneal Pharmaceuticals has agreed to commercialize ADL018 once approved in the US. We reported in November 2023 on the progress of omalizumab biosimilars through research and … Continue reading Kashiv BioSciences Signs Deal With Amneal to Market Omalizumab Biosimilar in the US →

Pyzchiva® (ustekinumab-ttwe) received the FDA’s approval as a biosimilar to Stelara®, partners Samsung Bioepis and Sandoz announced on July 1. The approval applies to the full set of autoimmune indications of the reference product. In addition, Pyzchiva was given “provisional” approval as an interchangeable product, which means that it cannot be used as such until … Continue reading Partners Samsung Bioepis and Sandoz Obtain FDA Approval for Third Ustekinumab Biosimilar →

On July 1, Formycon AG announced the FDA approval of the third aflibercept biosimilar; the new drug will be called Ahzantive® (aflibercept-mrbb). Two biosimilars were approved in late May, and the market for Eylea® biosimilars may get even more crowded: Amgen and Celltrion are awaiting FDA decisions in 2024 on their own biosimilar candidates. Formycon … Continue reading Formycon AG Receives FDA Nod for Ahzantive, an Aflibercept Biosimilar →

On June 27, Coherus Biosciences announced the sale of Yusimry, its low-concentration biosimilar of adalimumab, to a Chinese company for $40 million. The buyer’s US subsidiary, Meitheal Pharmaceuticals, will take over all US commercial activities after the purchase of Yusimry. According to Meitheal’s press release, they expect “additional indications, including a high-concentration formulation, to be … Continue reading Coherus Exits the Adalimumab Biosimilar Market With Sale of Yusimry® →

Biosimilars for ophthalmologic indications are expected to save payers and the health system a great deal of money, based on the assumption that the comparator product (generally a reference product) is costly. However, this is not really the case. The most commonly used biologic for indications such as age-related wet macular degeneration or retinal vein … Continue reading Will MDs Use Bevacizumab Biosimilars to Treat Retinal Disorders? One Report Says Yes →

A draft guidance by the US Food and Drug Administration signals the agency’s admission that the data on biosimilar switching is now comprehensive and persuasive. If these draft recommendations  are unchanged in the final guidance document, expensive biosimilar switching studies will no longer be needed for a manufacturer seeking the interchangeability designation. The draft guidance, … Continue reading FDA on Switching Studies to Demonstrate Interchangeability: Don’t Bother, We’re Convinced →

Soon after the initial introduction of infliximab in the late 1990s, physicians and researchers noticed that for patients with inflammatory bowel disease (IBD) who responded to therapy, a significant portion would experience loss of response over time. As a result, intensifying the dose of infliximab was found to be useful in maintaining remission. In fact, … Continue reading The Need for Dose Escalation in IBD: Another Cost-Savings Advantage for Biosimilars? →

Last year, we interviewed Dr. Niazi on a range of topics relevant to biosimilar development. We followed-up with him recently to get his thoughts on some recent developments in the field. Dr. Niazi is Adjunct Professor of Pharmaceutical Sciences at the University of Illinois and the University of Houston, founded the first US biosimilar company, … Continue reading Streamlining Biosimilar Development: Following up With Sarfaraz K. Niazi, PhD →

On May 28, 2024, the FDA approved Amgen’s Bkemv™ (eculizumab-aeeb) as the first biosimilar for Alexion’s Soliris®, a complement inhibitor. The biosimilar was approved as interchangeable and for the following indications: Bkemv, like the reference product Soliris, has a black box warning for the elevated risk of serious and life-threatening meningococcal infections caused by Neisseria … Continue reading Amgen Scores FDA Approval of First Eculizumab Biosimilar →

By Jocelyn Collura, PharmD Specialty pharmacy is a crucial link in the pharmaceutical supply and distribution chain, particularly for biologics and biosimilars covered under the pharmacy benefit. In this post, we asked a specialty pharmacy executive to discuss the ways in which organizations like her own contribute to the adoption of biosimilars. The US biosimilar … Continue reading The Role of Specialty Pharmacies in the Selection and Adoption of Biosimilars →

Biosimilar manufacturers have been desperate to obtain utilization for their products in the adalimumab marketplace, leading to some interesting arrangements with pharmacy benefit managers (PBMs). The first one implemented was CVS Health’s partnership with Sandoz under the banner of its subsidiary Cordavis. Boehringer Ingelheim signed a separate deal with Evernorth, including its PBM Express Scripts. … Continue reading Is Cordavis a Biosimilar Manufacturer, Distributor, or Marketer? →

Both Biocon and partners Samsung Bioepis/Biogen have reason to cheer today: The FDA approved their respective aflibercept biosimilars, Yesafili (aflibercept-yszy) and Opuviz (aflibercept-jbvf), for the following indications: With its announcement, the regulator has further clouded the issue of interchangeability (if that was even possible). The FDA designated both agents as interchangeable, which doesn’t seem feasible … Continue reading FDA Approves Two Interchangeable Aflibercept Biosimilars →

In early May, manufacturers reported their first-quarter earnings. These earnings reports usually have some valuable information about the company and industry as a whole. BR&R listened in on a few of them to pick up some morsels that point to the important industry trends. Coherus’ On-Body Injector On the biosimilar side of its portfolio, Coherus … Continue reading Learnings From Their Earnings (Reports) →

Tucked away in its first-quarter’s earnings report was the notice that Celltrion had filed its 351(k) application for approval of CT-P39 in March 2024. This could yield an FDA decision in the first or second quarter of 2025. We reported last November that Celltrion was indeed leading the pack in the omalizumab biosimilar race. With … Continue reading Celltrion Files for First Xolair® Biosimilar Approval in US →

Accord BioPharma announced the FDA approval of its first biosimilar, Hercessi® (trastuzumab-strf), marking also the 50th biosimilar approval by the FDA. “The approval of Hercessi—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” said Chrys Kokino, U.S. president of Accord. “Because breast … Continue reading 50th Biosimilar Approved by FDA, a First for Accord BioPharma →

This year’s annual meeting of the Academy of Managed Care Pharmacy featured several biosimilar-themed posters and presentations. Discussion of interchangeability and the efforts to remove the designation were prevalent, especially through legislative means (e.g., Senate Bill 2305). IPD Analytics gave their popular update on the specialty and biosimilar pipeline. Presenters Jeffrey Casberg, PharmD, and Leslie … Continue reading Biosimilars a Common Topic at AMCP Annual Meeting →

Cigna and its pharmacy benefit manager (PBM) Express Scripts has announced that starting June 1, adalimumab biosimilars by Boehringer Ingelheim and Alvotech/Teva will be available to its Evernorth members at a zero copay or co-insurance. The deal comes on the heels of reports of rising biosimilar prescriptions resulting from the CVS Caremark’s preference for another … Continue reading Cutting Out-of-Pocket Costs to Zero for a Biosimilar →

Ahead of next year’s expected launch of biosimilars to reference product Stelara®, partners Alvotech and Teva have been given FDA approval for Selarsdi (ustekinumab-aekn), the second of at least five ustekinumab biosimilars awaiting an FDA decision. Last year, the partners signed an agreement with Johnson & Johnson, allowing a launch of Selarsdi on February 21, … Continue reading Second FDA Approval for a Ustekinumab Biosimilar: Alvotech and Teva’s Selarsdi™ →

For the past several years, I’ve anticipated our gatherings in San Diego at the Festival of Biologics USA meetings. The topics addressed, the speakers, the attendees’ side discussions all bring to focus the state of the industry and how it changes over subsequent Spring conferences. This year, it was all about biosimilar industry sustainability. There … Continue reading Biosimilar Opportunities and Barriers, From the 2024 Festival of Biologics Meeting →

With a patent expiration still 4 years off, biosimilar makers are positioning themselves for a new biologic drug category, which may represent a greater opportunity than even adalimumab. Pembrolizumab (reference drug Keytruda®, manufactured by Merck) looms on the horizon, tantalizing the biosimilar community within a new oncology category. Pembrolizumab is the 800-pound gorilla of the … Continue reading The Next Huge Biologic Target in the Crosshairs of Biosimilar Manufacturers →

A study by IQVIA on adalimumab biosimilar savings found billions of dollars in lost opportunities in 2023, primarily because of pharmacy benefit managers’ (PBMs’) incentives to block biosimilar use. AbbVie’s financial statements indicate that Humira® net US sales revenues were more than $6 billion lower in 2023 compared with 2022. IQVIA’s study asserts that an … Continue reading IQVIA Study Confirms Large Lost Savings Opportunity With Adalimumab Biosimilars, Points the Finger at PBMs →

A European study of patients with inflammatory bowel disease (IBD) who initiated therapy with Humira® or an adalimumab biosimilar, or switched to a biosimilar found that outcomes and satisfaction were extremely high among all cohorts. But that statement is not surprising, based on cumulative experience with biosimilars. The study does suggest another very relevant conclusion, … Continue reading Real-World Evidence Says This Formulation Difference May Be a Nonissue for Adalimumab Biosimilars →

For those of us who are ready to see significant relief in the biosimilar regulatory process, the Biden Administration’s 2025 budget proposal promises an important step. If this line item in the budget proposal remains untouched, the interchangeability designation will be relegated to history. The President’s budget proposal would “permit biosimilar substitution without FDA determination … Continue reading Is the Demise of the Biosimilar Interchangeability Designation at Hand? →

Adding to the flurry of recent biosimilar approvals, on March 7, Fresenius Kabi became the latest to receive an FDA nod. Their product, Tyenne, a tocilizumab biosimilar (reference product Actemra®), is the second drug in the category to receive approval. Tyenne (tocilizumab-aazg) is approved to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, … Continue reading Fresenius Kabi Receives FDA Approval for Tyenne®, a Tocilizumab Biosimilar →

We have spent considerable digital space on the lack of uptake of the part D (pharmacy benefit) biosimilars and its potential consequences for future biosimilar development. We have contrasted that with the overwhelming success of the part B (medical benefit) biosimilars in terms of cost savings and dominant biosimilar uptake in those drug categories. Yet, … Continue reading Part B Biosimilar Sustainability Also in Question →

The US Food and Drug Administration announced that Sandoz has won the race to bring a denosumab biosimilar to the finish line. The reference product by Amgen (sold under the Prolia® and Xgeva® brands) will face competition from Jubbonti®, and Wyost®, respectively. Furthermore, the FDA has designated the biosimilar as interchangeable. The assigned nonproprietary name … Continue reading Sandoz Lands First Denosumab Biosimilar Approval, With Interchangeability Designation →

I had the pleasure of attending a truly valuable meeting this past weekend in Miami, called the Access Forum 2024. The conference offered expert perspectives on pharmaceutical market access in today’s rapidly changing environment. Before the COVID-19 pandemic, the ability of pharmaceutical representatives to visit individual physician practices and speak with the prescribers was already … Continue reading Market Access, Drug Development, and the IRA →

On February 23, 2024, a press release by partners Alvotech and Teva revealed that their long journey to obtain an approval for their adalimumab biosimilar was complete. The FDA designated Simlandi® (adalimumab-ryvk), a high-concentration formulation, as interchangeable with Humira®, making it the first interchangeable version of this most commonly used formulation. The drug is approved … Continue reading FDA Oks Alvotech/Teva’s Interchangeable, High-Concentration Adalimumab Biosimilar →

If you know any payer or self-insured employer who has a pharmacy benefit management contract with one of the big 3, you also know someone who is screaming for greater transparency into the value they are receiving. Even if the payer or employer requests and receives all available reporting from the PBM, they will not … Continue reading The Need for Transparency in Pharmacy Benefits: What Does It Mean for Biosimilars and Beyond? →

Economic challenges weighed heavily in the air at the annual meeting of the Association for Accessible Medicines (AAM) called Access2024. These economic challenges cast a pall over both the generic and biosimilar presentations. Although the two areas are related in objective, they are experiencing enormous pressure from multiple sides. The generic drug industry is facing … Continue reading Generics and Biosimilars: Similar Economic Challenges, Different Magnitudes →

A lawsuit filed by Johnson & Johnson employees against the drug manufacturer’s employee benefits operation on February 6 spotlights the potential, substantial liability for self-insured employers not adequately managing their pharmacy benefits. At issue is the money overpaid by J&J’s self-funded health plans  for medications used by its members. Ann Lewandowski, a healthcare policy and … Continue reading The Employer Is a Fiduciary for Its Employees Under ERISA, not an ATM for Its PBM →

Outlook Therapeutics’ hopes for a manufactured version of bevacizumab for ophthalmologic use have been significantly delayed. And its recent announcement that it is now targeting the end of 2024 for submitting its revised 351(a) application may push launch off until late 2025. The problem stems from Outlook Therapeutics’ initial clinical trial results, described in the … Continue reading Outlook’s Dimming Outlook and Celltrion’s New FDA Biosimilar Submission →

On January 22, Sandoz announced that it acquired the ranibizumab biosimilar Cimerli® from Coherus Biosciences for upwards of $190 million. First approved on August 2, 2022, Cimerli was performing well. According to its manufacturing partner, Formycon AG, the product had grabbed 38% of the ranibizumab marketshare (based on IQVIA data), with $125 million in 2023 … Continue reading Implications of the Cimerli® Sale →

Earlier this month, Accord BioPharma announced that it had submitted its 351(k) biosimilar application to the FDA for DMB-3115, a proposed ustekinumab biosimilar. An FDA decision may come as early as late Q4 2024. The application for DMB-3115 includes study results from a phase 3 clinical trial in patients with plaque psoriasis, in which DMB-3115 … Continue reading Accord BioPharma Seeks FDA Approval for DMB-3115, an Ustekinumab Biosimilar →

As I look back on 2023, the frustration and concern on behalf of the biosimilar industry is inescapable. For adalimumab biosimilar manufacturers, it was a lost year. Period. The adalimumab market represents the greatest opportunity for biosimilar makers since the approval of Zarxio®, the first biosimilar approved in the United States. It is certainly the … Continue reading What Does the 2023 Adalimumab Biosimilar Story Foretell in 2024? →

CVS Health announced on January 3 that it will exclude AbbVie’s Humira from its standard national formularies, effective April 1, 2024. As a result, CVS Caremark has become the first major pharmacy benefit manager (PBM) to exclude of Humira in favor of biosimilars with “a significantly lower list price than the reference product,” according to … Continue reading CVS Moves to Exclude Formulary Coverage of Humira® →

The Food and Drug Administration published research late last month that showed greater use of biosimilars by patients covered under Medicare Advantage (MA) plans than traditional or fee-for-service (FFS) Medicare. Based on claims and encounter data for Medicare recipients from May 2015 through September 2022, the researchers included 20 biosimilars (7 drug categories) typically covered … Continue reading New Research Shows Greater Biosimilar Utilization in Medicare Advantage →

On December 26, 2023, Coherus Biosciences announced the end of its long journey to bring competition to the full pegfilgrastim product line. The FDA has approved its on-body injection formulation to compete with Amgen’s Neulasta OnPro®. In Coherus’ press release, Danny Lanfear, CEO, stated, “The on-body injector for Udenyca is the result of years of … Continue reading FDA Hands Coherus Approval for Udenyca® Onbody™ Injector →

On December 7, the Guangzhou, China–based manufacturer Bio-Thera Solutions announced that it had received FDA approval for its bevacizumab biosimilar. Dubbed Avzivi® (bevacizumab-tnjn), the agent will be marketed (globally) by Sandoz. The drug is indicated for: The biologic licensing application for BAT1706 (the original investigational name for the agent) included the results of a phase … Continue reading Bio-Thera Scores Its Second US Biosimilar Approval, Avzivi® →

In the years since the authorization of the BPCIA in 2010 and the drafting of the US biosimilar pathway in 2012, the Food and Drug Administration has given those in the biosimilar field plenty of complexities and ambiguities to debate. And we, in this column certainly have. First was the notion of adding four-character suffixes, … Continue reading Interchange or Change? →

As reported by the Center for Biosimilars, CVS Caremark has announced their 2024 formulary changes. Some of which, especially in the ophthalmology area, are particularly interesting and may shake up the category for wet, age-related macular degeneration. The large PBM decided to exclude from coverage the reference product for aflibercept (Eylea®) despite aflibercept biosimilars having … Continue reading CVS Caremark’s Formulary Changes: Eye Pain for Eylea →

Omalizumab is a versatile IgE inhibitor used to treat three indicated conditions: chronic urticaria (a systemic allergic reaction manifested by hives), rhinosinusitis with nasal polyps, and persistent and severe symptoms of allergic asthma. According to the reference product manufacturer, Genentech (a subsidiary of Roche), Xolair’s 2022 US revenues were $2.5 billion, a 9% increase over … Continue reading When Will a Biosimilar Version of Xolair® be Available? →

Over the past month, several developments have been noted in the adalimumab product space, and we summarize them below. First, according to its early October press release, Pfizer planned to launch its interchangeable biosimilar Abrilada® by the end of that month. Pfizer’s switching studies were carried out using the low-concentration formulation (LCF), so it is … Continue reading A Busy Month for Biosimilar Adalimumab Product Updates →

On October 31, the FDA announced that Amgen’s biosimilar ustekinumab has won approval as an interchangeable product, marking the first biosimilar approval in this drug category and the first biosimilar for any interleukin agent. Dubbed Wezlana (ustekinumab-auub), the biosimilar is approved for all of Stelara’s indications, including: moderate-to-severe plaque psoriasis (adults and children ≥ 6 … Continue reading First Biosimilar Interleukin Approved by the FDA: Amgen’s Wezlana™ Is Interchangeable with Stelara® →

Coherus Biosciences has sought to develop an on-body injector formulation of its pegfilgrastim biosimilar Udenyca® that can provide long-awaited competition to Amgen’s Neulasta OnPro. The company suffered a setback when the FDA issued a complete response letter in September, not accepting its supplemental biologic licensing application (BLA). The BLA was rejected because of inspection issues … Continue reading Update on Coherus’ Quest for Neulasta OnPro® Competitor →

On October 23, the FDA approved a new biologic follow-on agent that may significantly affect the US biosimilar industry. Monday’s approval of Celltrion’s subcutaneous (SC) form of infliximab could upset the apple cart on biosimilars uptake in this important drug category. The new drug, dubbed Zymfentra® (the nonproprietary name, infliximab-dyyb, is the same as for … Continue reading Celltrion Scores FDA Approval of SC Infliximab: Will Use of the IV Formulation Be Affected? →

One of the great unknowns of the fierce competition in the biosimilar drug categories has always been what happens when a “pricing floor” is reached. How will payers react? We have heard often that payers may consider reimbursing only at a reference price level (not to be confused with a reference product), which represents the … Continue reading A Biosimilar Mainstay Faces an ASP Cliff →

The Office of the Inspector General (OIG) issued a new report in late September on savings associated with part B biosimilars, reiterating that the Medicare program could have saved $419 million in 2021 if it did more to incentivize biosimilar utilization. Similarly, a panel discussion at last week’s GRx+Biosims meeting emphasized that adoption for medical … Continue reading The Push and Pull of Buy and Bill for Biosimilars on the Medical Benefit →

Several precarious issues were on everyone’s mind at this year’s GRx+Biosims meeting, organized by the Association for Accessible Medicines. This conference combines the interests of generic manufacturers and biosimilar makers, and one particular speaker, emphasized where these interests meet today: the sustainability of both industries. Christine Baeder, Senior Vice President, US Generics, Teva, pointed out … Continue reading Biosimilars, Generics, and the Sustainability Nexus →

Partners Biogen and Bio-Thera announced on September 29 that they received US approval for Tofidence™ (tocilizumab-bavi), the first biosimilar for the interleukin-6 drug category. The drug is approved for the same indications as the reference product Actemra: treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Formerly … Continue reading The First Biosimilar for Actemra® is Approved by FDA →

Samsung Bioepis announced this week that it had signed a commercialization agreement with Sandoz regarding their investigational biosimilar ustekinumab candidate SB17. This is Samsung Bioepis’ first marketing agreement with Sandoz; the company has marketing agreements in place with Organon for  Renflexis® (infliximab), Hadlima® (adalimumab), and Ontruzant® (trastuzumab); and with Biogen for Byooviz®. In response to … Continue reading Sandoz to Market Samsung Bioepis’ Ustekinumab Biosimilar →

The quest for a manufactured ophthalmologic version of bevacizumab continues. The use of compounded bevacizumab has been considered a low-cost alternative to ranibizumab for the treatment of wet age-related macular degeneration (AMD). This may comprise up to half of the wet AMD utilization. Outlook Therapeutics, which has sought to bring its ONS-5010 product to market, … Continue reading Outlook Therapeutics Gets FDA Rejection on Its Ophthalmologic Bevacizumab Formulation →

In early August, partners Fresenius Kabi and Formycon announced that they had reached an agreement with Johnson & Johnson to launch FYB202, if approved by the FDA, “no later than April 15, 2025.” Later that month, Celltrion finalized its patent agreement for CT-P43, enabling a launch in March 2025. Celltrion had filed its 351(k) application … Continue reading Two More Patent Settlements and Launch Dates for Ustekinumab Biosimilars →

With the announcement today of the first 10 drugs to be subject to the Medicare price negotiation provisions of the Inflation Reduction Act, three of these agents are of interest to the biosimilar community—Enbrel®, Stelara®, and NovoLog®. With the initial implementation date of the newly “negotiated” prices set for January 1, 2026, it is likely … Continue reading Three Biosimilar Targets in CMS’s Sights →

On Wednesday August 23rd, CVS Health released information regarding an agreement with Sandoz, which will start its new venture called Cordavis in 2024. The fact that this agreement centers around Sandoz’s adalimumab biosimilar Hyrimoz® raises questions regarding the strategy and potential value of this option. Sandoz introduced Hyrimoz in July of this year with both … Continue reading What is Cordavis and Why Will It Be Important to CVS Health and Biosimilars? →

On August 24, the FDA announced that it had approved its 42nd biosimilar—Sandoz’s Tyruko® (natalizumab-sztn), a new biosimilar agent for the treatment of relapsing forms of multiple sclerosis (MS) (an initial clinically isolated occurrence, relapsing-remitting disease, and secondary progressive disease). As with the reference product Tysabri®, Tyruko is also indicated to induce and maintain clinical … Continue reading Sandoz Notches Approval of Tyruko, First Biosimilar to Treat Multiple Sclerosis →

I’m not sure if you saw it, but leading biosimilar industry scientists/advocates published in BioDrugs an exemplary summary of the steps regulators may take now to expand the biosimilar pipeline tomorrow. Importantly, these steps are not recommended to improve profits but because the regulatory science and biosimilar experience fully supports it. The article, written by … Continue reading Simplifying Biosimilar Development to Ensure Long-Term Competition →

In the mass of adalimumab launches in July, it may be tough to spot the one missing player. This is not a game of Where’s Waldo? but rather, where’s Pfizer’s Abrilada™? Well, that’s a good question. Of the competitors that have gained FDA approval, they are the only manufacturer that did not launch its product … Continue reading Where’s Pfizer’s Adalimumab Biosimilar? →

Ranibizumab (Lucentis®) was the first opportunity for biosimilar manufacturers in the lucrative ophthalmology market. Not withstanding the potential launches of biosimilars for market-leader aflibercept (Eylea®), which holds the greatest marketshare, and the performance of other biobetters or brands (Vabysmo®, Susvimo®), some early ranibizumab biosimilar uptake is occurring. However, a third competitor, which may be crucial … Continue reading Ranibizumab Biosimilar Updates: A Nascent Market but Limited Competition →

With the reporting of AbbVie’s second-quarter earnings, we are getting a better understanding of the substantial savings accruing to the US health system as a result of biosimilar competition. AbbVie reported yesterday that net US revenues from Humira dropped 26% in the US for the six months ending June 30th to $6.4 billion. For the … Continue reading Projecting at Least 40% Lower 2023 Humira® Net Costs in US →

In the 2½ years since we last updated the denosumab biosimilar pipeline, several new manufacturing/commercialization partners have emerged on the horizon, and the first 351(k) application has been filed with the Food and Drug Administration (FDA). As importantly, denosumab, along with ustekinumab, appears to be one of the most hotly contested biosimilar categories for the … Continue reading Twelve Potential Competitors and Counting: An Update of the Denosumab Biosimilar Pipeline →

A new senate proposal seeks to remove the Food and Drug Administration’s (FDA’s) interchangeable designation. If passed, it would enable all biosimilars to be considered interchangeable with their individual reference products. The Biosimilar Red Tape Elimination Act was introduced July 13, 2023 by Senators Mike Lee (R-UT), Ben Ray Lujan (D-NM), Mike Braun (R-IN), and … Continue reading An Attempt to Eliminate the Interchangeability Designation →

A tidal surge of biosimilar competitors to Humira® launched this week, with at least a couple of surprises. Last month, Coherus announced their huge price discount, based on the reference product’s wholesale acquisition cost (WAC). Samsung Bioepis/Organon has decided to meet that 85% discount. None of the other competitors raised the ante, but Sandoz and … Continue reading The Adalimumab Biosimilar Great Wave Launches, and WAC Pricing Covers the Spectrum →

We are heading down the home stretch for the July launches of multiple adalimumab biosimilars, and much is occurring that is noteworthy. Coherus’ announcement earlier this month that it will be discounting 85% off of Humira®’s list price set off a great deal of discussion. The implications can be far reaching, for payers, the reference … Continue reading Adalimumab Biosimilar Savings Will Cause Payers to Rejoice, for the Short-Term Anyway →

As reported in late May, Amgen settled with Johnson & Johnson to launch its biosimilar version of Stelara® by January 1, 2025. That signaled the beginning of licenses being provided to the other manufacturers, confirmed by an agreement between Alvotech and the reference drug maker. According to the June 12 press release, Alvotech and its … Continue reading Second Prospective Ustekinumab Biosimilar Maker Signs Licensing Agreement With J&J →

In time for its expected July launch, Celltrion USA received the FDA’s go-ahead yesterday to market Yuflyma, a high-concentration form of adalimumab. Its nonproprietary name is adalimumab-aaty. The biosimilar’s approval covers the eight main indications shared by the other approved biosimilars for adalimumab: This represents Celltrion’s fifth biosimilar approval in the US, and its second … Continue reading Celltrion’s Adalimumab Biosimilar Yuflyma® Receives FDA Approval →

Ustekinumab’s principal patents are set to expire in September of this year, and prospective biosimilar makers are lining up to join this next immunology marketplace. However, in a patent litigation settlement announced on May 23, the launch of the biosimilars to Stelara® may have to wait a bit. Amgen’s settlement with the reference drug maker … Continue reading Amgen Settles With J&J: Its Ustekinumab Biosimilar to Launch by Jan 1, 2025 →

On May 1, Amgen filed a lawsuit in District Court against Sandoz and its former parent Novartis regarding patents on denosumab, sold under the Prolia® and Xgeva® brand names. The fact that the lawsuit was filed is not surprising, as BPCIA suits have been routinely filed in the past in an effort by reference manufacturers … Continue reading Why Aren’t There More Patent Cases Pending, Considering the Size of the Biosimilar Pipeline? →

We first met Thomas Nusbickel in 2014 when he was Hospira’s Head of US Market Access and involved with the commercialization of Hospira’s Retacrit®, slated at the time to become one of the first biosimilars approved by the FDA. Tom went on to a distinguished career in biosimilars, and he is currently leading the effort … Continue reading A Conversation with Thomas Nusbickel, Chief Commercial Officer, Senior VP, Celltrion USA →

On May 2, The Lannett Company Inc. disclosed that it had filed for Chapter 11 bankruptcy. The company has been working on an insulin glargine biosimilar candidate. On April 4th Lannett reported that its biosimilar insulin had met all primary and secondary endpoints and was not associated with serious adverse events. This was a pivotal … Continue reading Prospective Biosimilar Maker Lannett Files Chapter 11 Bankruptcy →

Yesterday marked two important earnings calls for the adalimumab market, and the results were mixed at best for both manufacturers involved. As everyone is well aware, 2023 is the year of adalimumab launches, and Amgen’s Amjevita® was the first to compete with AbbVie’s originator biologic Humira®. Launched on January 31, the question of how many … Continue reading First-Quarter Sales of Adalimumab Reveal Plenty of Savings, but Little Early Revenue for Amgen →

Dr. Niazi, Adjunct Professor of Pharmaceutical Sciences at the University of Illinois and the University of Houston, founded the first US biosimilar company, Therapeutic Proteins (later Adello and Kashiv), and is the founder of Novel351k, as well as a biosimilar advisory company PharmSci. In part 2 of this two-part interview, we talked with Dr. Niazi … Continue reading A Conversation With Sarfaraz K. Niazi, PhD: Part 2 →

I am appalled that this subject needs to be addressed. The US Food and Drug Administration (FDA) isn’t perfect, but it is still the global gold standard for evaluating medicines for safety and effectiveness. The FDA, though not quite recovered from the self-inflicted damage caused by the Aduhelm® approval mess, is staffed by scientists who … Continue reading The Drug Industry Rightly Fears Judicial Overreach →

Recently, we conducted a Web-based interview with someone who has been exceedingly important to the advancement of the biosimilar industry, Sarfaraz Niazi, PhD. Dr. Niazi, Adjunct Professor of Pharmaceutical Sciences at the University of Illinois and the University of Houston, founded the first US biosimilar company, Therapeutic Proteins (later Adello and Kashiv), and is the … Continue reading A Conversation With Sarfaraz K. Niazi, PhD: Part 1 →

An FDA Application Filed for a New Trastuzumab Biosimilar Accord BioPharma and its manufacturing partner Shanghai Henlius Biotech announced that the US Food and Drug Administration (FDA) accepted its 351(k) application for HLX02, a trastuzumab biosimilar candidate. The company is seeking similar HER2-overexpressing tumor indications as its competitors. If approved, it would be Accord’s first … Continue reading Biosimilar Bytes →

Of the several classes of agents used to treat wet age-related macular degeneration or diabetic macular edema, no one drug does a better job of improving vision than the others. The only differentiating feature of the available biologics involves the frequency of intravitreal injections. There are large differences in prices, however, and this is why … Continue reading Many VEGF Inhibitor Options for Macular Degeneration and Edema, but Bevacizumab Is Still the Cost-Effectiveness Champ →

Manufacturers of biosimilars realize that the US market comprises roughly 60% of global pharmaceutical revenues. Therefore, the US Food and Drug Administration’s regulatory standards weigh heavily on the minds of pharmaceutical executives. For companies that sell or intend to sell their biosimilars on the global market, they must adhere to the standards of regional and … Continue reading Advancing Global Harmonization of Biosimilar Evaluations →

The national news has been awash with announcements by the three major branded insulin manufacturers of price cuts of up to 80%. Sanofi was the last to announce its 78% insulin price cut. Lilly announced 70% reductions, and Novo Nordisk dropped its insulin prices by 75%. Importantly, the announcements were also accompanied by a $35 … Continue reading Insulin Price Cuts and the Questions for the Biosimilar Market →

Numerous groups are trying to determine which of Medicare’s high-cost medicines will be the first targets of the Inflation Reduction Act’s drug price negotiations in 2026. On March 13, Reuters published a list based on a Wall Street consensus. Earlier this month, researchers from the West Health Policy Center in Washington, DC, and Skaggs School … Continue reading Which Ten Medicines Will Be Medicare’s First Drug Price Negotiation Targets? →

On its 2022 earnings call last week, Coherus Biosciences revealed some promising tidbits but the overall impression is worrisome, just prior to its Yusimry® launch in July. During the earnings call, Coherus executives announced that it had filed for approval of the long-awaited, first competitor to Neulasta OnPro®. Last year, the company was hoping that … Continue reading Coherus’ Struggling Picture Prior to Udenyca On-Body Injector Approval and Yusimry Launch →

They love me, they love me not, they love me, they love me not… For several years, we’ve been reading surveys or hearing anecdotal reports that certain specialists are more willing than others to prescribe various biosimilars. For instance, it is widely accepted that oncologists have less resistance to biosimilar prescription than say gastroenterologists (GIs). … Continue reading How Much Does Provider Comfort With Biosimilar Prescribing Matter? →

One of the main thrusts of the recently passed BsUFA III legislation was to continue the evolution towards streamlining the clinical trial requirements for new biosimilar candidates. That process is seemingly moving forward with the request for funding opportunity proposals from the Food and Drug Administration (FDA) that “enhance biosimilar and interchangeable product development and … Continue reading FDA Seeking Help With Biosimilar Development Streamlining Process →

Among the Inflation Reduction Act’s many healthcare-related provisions, is the ability for Medicare to negotiate drug pricing for a subset of high-cost drugs. Payers and policy makers have sought this provision for several years. The pharmaceutical industry has been a fierce opponent, as one would expect. This week, the Department of Health and Human Services … Continue reading The Inflation Reduction Balancing Act on Rebate Clawbacks →

On February 6, Sandoz announced that the FDA has accepted its application for approval of a biosimilar to denosumab (reference brands, Prolia® and Xgeva®, from Amgen). Sandoz opted not to seek a “skinny label.” The application seeks Prolia’s full set of osteoporosis indications as well as Xgeva’s oncology indications (postmenopausal women and in men at … Continue reading Sandoz Sends 351(k) BLA to FDA for First Denosumab Biosimilar →

The adalimumab competition is officially open for business, and Amgen came out of the gate launching Amjevita in two WAC-based pricing options to appeal to a broad market. One of the biosimilar industry’s main concerns is that adalimumab, the first biosimilar antibody, will be funded and managed through the pharmacy benefit. As such, pharmacy benefit … Continue reading Amgen Launches Amjevita® With Two WAC-Based Pricing Options →

We are heading down the stretch for the most lucrative biosimilar market that may ever open in the US healthcare system. On January 31, Amgen will launch its long-awaited biosimilar Amjevita®. The opening of the long-delayed competition for adalimumab marks the latest and most important era in the biosimilar timeline. Personally, I’ve been writing about … Continue reading Put Your Money Where Your Mouth Is →

Alvotech has emerged first out of the blocks in the race to bring a Stelara® biosimilar to the US market. The company announced that the FDA accepted its 351(k) application for AVT02 on January 6, which should position it for a decision in the fourth quarter of this year. Alvotech had announced a successful conclusion … Continue reading Alvotech’s Ustekinumab Biosimilar Application With the FDA: Decision Expected Before End of Year →

In November 2019, Celltrion received approval in Europe for its subcutaneous (SC) form of infliximab. At that time, we speculated on the dramatic implications such an approval might have in the US. More than three years later, Celltrion’s US division announced that it had completed its 351(a) submission to the US Food and Drug Administration. … Continue reading Celltrion Files FDA Application for Subcutaneous Form of Infliximab →

On December 14, Fresenius Kabi announced that the US Food and Drug Administration approved its adalimumab biosimilar, Idacio (adalimumab-aacf). This is the eighth Humira® biosimilar approved, and Fresenius Kabi expects to launch the agent in July, along with several of its competitors. Idacio is a citrate-free, low-concentration dose formulation of adalimumab. The company has not … Continue reading 40th Biosimilar Approved: Fresenius Kabi Gets FDA’s Nod on Idacio® →

According to the Pharmaceutical Care Management Association (PCMA), biosimilars can play a much more influential role in managing the cost of specialty pharmaceuticals; however, the federal government will have to take stronger initiatives to make that happen. The trade organization’s white paper “PBMs Support the Proliferation and Use of Biosimilars” outlines some key steps that … Continue reading PBM Trade Association Offers Key Changes to Improve Biosimilar Competitiveness →

Competition is heating up in a new drug category. Biogen announced today that the FDA has accepted its biosimilar application for BIIB800 (also known as BAT1806), a potential competitor to the reference product Actemra (tocilizumab). This is the second tocilizumab biosimilar sent for approval by the FDA. In August, Fresenius Kabi announced that it filed … Continue reading Biogen Announces Submission of Its 351(k) Application for Actemra® Biosimilar →

Patent litigation over biosimilars charges forward, with a new lawsuit filed on November 29 by Johnson & Johnson’s Janssen unit over Amgen’s efforts to bring a ustekinumab biosimilar to the marketplace. Stelara is expected to be a hotly contested market, with five manufacturers completing phase 3 trials through the first half of 2023. The principal … Continue reading J&J Slaps Patent Suit on Amgen Over Impending Stelara^® Biosimilar →

It has been a busy year for biosimilars at Biogen, starting early in the year with with the sale of its stake in Samsung Bioepis. During Global Biosimilars Week, we interviewed Ian Henshaw, Biogen’s Senior Vice President and Global Head of Biosimilars, to get his perspectives on what the coming year has in store. BR&R: … Continue reading A Conversation With Ian Henshaw →

On November 16, the Food and Drug Administration (FDA) granted its second interchangeable designation to an insulin glargine product, Rezvoglar®, manufactured by Eli Lilly. Rezvoglar was first approved as a biosimilar in December 2021. Viatris’ Semglee® was the first glargine product given the interchangeable designation, in July 2021 (it was originally approved as a 505(b)2 … Continue reading Lilly’s Rezvoglar Joins the Ranks of the Interchangeable Insulins →

This week, OptumRx announced that AbbVie’s Humira® will not be the sole covered adalimumab product in 2023 and it will not be advantaged over biosimilars. The announcement made at an HLTH conference on November 15 was the first official pronouncement by a major pharmacy benefit manager (PBM) regarding adalimumab coverage plans. Heather Cianfrocco, CEO of … Continue reading OptumRx Reveals a 2023 Decision on Adalimumab Biosimilars →

Since the adalimumab biosimilars are typically covered under insurers’ and health plans’ pharmacy benefit, pharmacy benefit managers (PBMs) will be the key drivers of these upcoming coverage decisions. Pharmacy benefit managers and their client health plans and self-funded employers do not necessarily have the same incentives. This is unfortunate, and may cause issues in the … Continue reading What We May Have Here Is a Failure to Communicate →

One of the main societal benefits of biosimilar introductions has always been to create savings that can be used to finance the utilization of future novel agents. The introduction of generic drugs saved the US healthcare system billions from the 1980s through 2010, and this money helped finance our ability to pay for specialty pharmaceuticals. … Continue reading Can Biosimilars Fund New Specialty Pipeline Development? →

BBCIC Wins $1.3 Million FDA Grant The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced receiving a two-year grant for a new study focused on increasing the efficiency of biosimilar drug development and review. The study is entitled “Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce … Continue reading Biosimilar Bytes →

On September 28, the Food and Drug Administration (FDA) approved Celltrion’s Vegzelma™, a biosimilar to Roche’s Avastin®. Dubbed bevacizumab-adcd, this vascular endothelial growth factor (VEGF) is indicated for the treatment of: Recurrent or advanced nonsquamous non–small cell lung cancer Metastatic renal cell carcinoma Recurrent glioblastoma Recurrent or advanced cervical cancer Epithelial ovarian cancer Fallopian tube … Continue reading Celltrion Earns FDA Nod for Bevacizumab Biosimilar →

At last week’s DIA Biosimilar 2022 conference in Arlington, Virginia, speakers from the Food and Drug Administration (FDA) were optimistic that the current BsUFA III proposal would be voted on and signed into law shortly, and they focused on some of the larger issues addressed by the bill. Jacqueline Corrigan-Currey, MD, JD, Principal Deputy Director … Continue reading FDA’s BsUFA III Features →

The Law of Unintended Consequences is an axiom of legislating proved over and over again by the US Congress. In major legislation, there are always issues that (1) were not fully considered in writing the bill or (2) are a direct, unexpected consequence of the law’s implementation. The reconciliation route used to create and pass … Continue reading The Inflation Reduction Act: Reducing Drug Prices and Maybe Future Biosimilar Development →

The argument has been raging for many years: What is the actual cost to bring a novel drug to market? The oft-cited figure from the 2014 Tufts Center for the Study of Drug Development of $2.6 billion seemed bloated. Several others have countered that the figure is actually far lower, perhaps a mean of $1.3 … Continue reading Can Biosimilar Development Costs Be “Genericized”? →

On September 6, Fresenius Kabi announced that it had received FDA approval for Stimufend® (pegfilgrastim-fpgk). This agent will be marketed in 2023, according to the company. The first US biosimilar approval for Fresenius Kabi, Stimufend is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile … Continue reading FDA Approves Fresenius Kabi’s Pegfilgrastim Biosimilar Stimufend →

Alvotech and Teva plan to launch ATV02, their high-concentration, citrate-free, interchangeable biosimilar version of Humira® in July 2023. However, the US Food and Drug Administration (FDA) issued the company a complete response letter this week, citing Alvotech’s manufacturing issues, which could delay those plans. The FDA has been catching up on facility inspections (see also … Continue reading Alvotech’s Adalimumab BLA Tripped Up by FDA →

On August 17, the Food and Drug Administration granted approval to partners’ Samsung Bioepis and Organon for its new formulation of Hadlima™. This adalimumab biosimilar is now approved for use in a citrate-free, high-concentration formulation, in addition to its low-concentration, non–citrate free version that was approved in July 2019. In its press release, Samsung Bioepis’ … Continue reading Samsung Bioepis and Organon Score Citrate-Free, High-Concentration Dose Approval →

This IL-6 is approved for treating several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Roche’s reference product Actemra® was also the subject of an Emergency Use Approval for the treatment of COVID-19. In 2021 Roche’s U.S. sales of Actemra totaled $1.9 billion. In a second-quarter … Continue reading Tocilizumab Biosimilars Approaching: Developments on Three Fronts →

AbbVie has successfully defended against a suit that accused the Humira® maker of violating antitrust laws by agreeing to settlements with all of the other biosimilar adalimumab makers and that it impeded competition through its filing of 132 patents on the drug. U.S. Circuit Court Judge Frank Easterbrook ruled on August 1 that the patent … Continue reading Appeals Court Says “So What?” to Patent Thickets →

In a couple of firsts, the U.S. Food and Drug Administration (FDA) approved the second biosimilar ranibizumab on August 2, but the first as an interchangeable ranibizumab agent and the first as an interchangeable that did not require extensive switching studies for approval. The new biosimilar, named Cimerli (ranibizumab-eqrn), will be marketed in October 2022 … Continue reading Coherus Scores Approval of Cimerli® as Interchangeable Ranibizumab Biosimilar →

In the second part and conclusion of our conversation, Dr. Oskouei and I discuss several other interesting aspects of switching among products within a drug category, including biosimilars and follow-on agents, the potential barriers to switching in the ophthalmology category, and how to collect data on biosimilar switching. Stanton Mehr, Content Director, BR&R: We can … Continue reading A Conversation With Sonia T. Oskouei, PharmD, Vice President of Biosimilars, Cardinal Health: Part 2 →

In part 1 of this conversation, Dr. Oskouei and I take a deep dive into biosimilar-to-biosimilar switching, a potentially confusing topic that will grow in importance within the next couple of years. (Note: See also the BR&R post on a new study released this week on the safety of biosimilar-to-biosimilar switching—S.M.) Stanton Mehr, Content Director, … Continue reading A Conversation With Sonia T. Oskouei, PharmD, Vice President of Biosimilars, Cardinal Health →

A multinational group of researchers conducted a systematic review of the real-world data collected when patients taking one biosimilar switch to another biosimilar for the same reference product. They assessed 626 reports of biosimilar switching, which were screened for duplication and validity, resulted in a comprehensive evaluation of 23 peer-reviewed articles and abstracts, comprising 3,657 … Continue reading New Systematic Review Gives Thumbs up to Biosimilar-to-Biosimilar Switching →

On July 25, Sandoz announced that the Food and Drug Administration has accepted its 351(k) application for the first biosimilar in the multiple sclerosis category. Developed by its partner Poland-based Polpharma Biologics, PB006 is a natalizumab biosimilar (reference product, Biogen’s Tysabri®). The agent is an integrin-receptor antagonist that has been prescribed since 2004. Sales revenues … Continue reading Sandoz Submits 351(k) Application for Biosimilar Natalizumab to Treat MS →

Biosimilar makers continue to supplement their biosimilars’ profile in an effort to produce the most attractive offering to payers. In the latest news, Sandoz announced that it filed a supplemental application with the Food and Drug Administration (FDA) to gain approval for a high concentration and citrate-free formula. Sandoz’s adalimumab biosimilar Hyrimoz® was initially approved … Continue reading Prelaunch Adalimumab Updates Keep Coming: Sandoz’s Filing on Hyrimoz →

With the approval of the first ranibizumab biosimilar and its launch by Samsung Bioepis/Organon earlier this month, the question arises as to whether this drug will be covered under the medical or pharmacy benefit. Typically, biologics infused or injected in the provider’s office are covered under the medical benefit for commercial insurers or Part B … Continue reading Self-Injectable Biosimilar Drugs and the Pharmacy Benefit →

In February 2020, the Food and Drug Administration issued a six-page draft guidance for biosimilar makers seeking licensure for only some of the reference product’s indications. “It’s bare bones for a reason,” said W. Blake Coblentz, Co-Chair, Hatch–Waxman and Biologics Litigation Group at the law firm Cozen O’Connor. “The FDA is encouraging the applicant to … Continue reading Skinny Labels From the Attorney’s Perspective →

I joined millions of Americans who took to the road and skies last week—not to celebrate the nation’s founding—but to attend my third symposium by the American Conference Institute on Innovative Biologics and Biosimilars. The differentiating feature of this meeting is that its primary focus is on the evolving patent and intellectual property (IP) arena … Continue reading A Dispatch From the Biosimilar World of IP and Patents →

On June 16th, Kaiser Health News released rather stunning information. A survey by the Kaiser Family Foundation and NPR found that upwards of 100 million Americans have unpaid medical debt. This is crucial to the question of biosimilar availability and the affordability of medicines in general. Whether you believe that medical debt is ubiquitous, inevitable, … Continue reading Can Biosimilars Help Reduce America’s Medical Debt? →

Samsung Bioepis announced that its eculizumab biosimilar candidate successfully completed its phase 3 trial in patients with paroxysmal nocturnal hemoglobinuria (PNH). The randomized, double-blind, crossover trial pitted the eculizumab biosimilar against the reference biologic Soliris® in 50 patients. Twenty-five patients received either SB12 or Soliris® 600 mg intravenously every week for 4 weeks, followed by … Continue reading Phase 3 Data on Samsung Bioepis’ Eculizumab Biosimilar Confirms Equivalence to Soliris →

Cedars-Sinai Health System had a 55% biosimilar substitution rate for its reference bevacizumab, rituximab, and trastuzumab agents prior to January 2021. At the American Society of Community Oncologists 2022 annual meeting, a poster presentation detailed a project to increase the health system’s biosimilar substitution rate substantially across its medical center and affiliated practice sites. None … Continue reading Cedars-Sinai Health System Leverages Oncology Biosimilar Savings Through Its EHR →

Scrutiny on pharmacy benefit managers (PBMs) has just been ratcheted up considerably. The Federal Trade Commission (FTC) announced on June 7 the launch of its investigation into PBM practices, targeting the largest players. This investigation comes at an extremely crucial time for the biosimilar industry, as manufacturers prepare to negotiate with these same PBMs for … Continue reading Federal Trade Commission to Investigate PBM Practices →

Approved in September 2021, partners Samsung Bioepis and Biogen have disclosed that their ranibizumab biosimilar Byooviz™ will be commercially available on July 1. The agent is approved by the U.S. Food and Drug Administration (FDA) to treat neovascular (wet) age-related macular degeneration, macula edema following retinal vein occlusion, and myopic choroidal neovascularization. Lower Biosimilar Cost … Continue reading Samsung Bioepis and Biogen Announce Launch of First Ranibizumab Biosimilar in US →

On May 27, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration granted approval to Fylnetra™ (pegfilgrastim-pbbk), a new biosimilar that will launch later this year. Amneal has been busy this year in the biosimilar area: This is its third biosimilar approval since January 1. The two earlier approvals, for filgrastim and bevacizumab biosimilars, … Continue reading Partners Amneal and Kashiv Score Approval From FDA for Their Pegfilgrastim Biosimilar →

Can biosimilars be called successful if a minority are designated preferred products on formulary, but not all? What if the net-cost savings associated with a biosimilar is 30% lower, but not 60% than a reference biologic a few years postlaunch? Or the marketing of a biosimilar stopped the annual price increases of the reference drug? … Continue reading What Does Success Look Like in the Biosimilar Arena? →

Since the conception of the biosimilar regulatory pathway in 2010, the term extrapolation has caused confusion and angst for many health system stakeholders. Would the Food and Drug Administration (FDA) approve a biosimilar for all of the reference product’s autoimmune indications, for example, if its clinical studies were in one or two indications only? Mostly, … Continue reading More Confirmation that Payers Will Cover Beyond the Skinny Label →

Coherus Biosciences thinks it will be able to amp up its Udenyca® sales in 2023, by introducing a competitor on-body injector to Neulasta OnPro®. According to IQVIA data, Amgen’s Neulasta OnPro currently has about half of the marketshare for the entire pegfilgrastim category. Biosimilars hold approximately 30% of the total uptake, and Coherus’ product is … Continue reading Competition Squeezes Coherus’ Pegfilgrastim Revenues: Big Expectations for its On-Body Injector →

For the first several years of biosimilar research, approvals, and launches, we wondered aloud whether payers could potentially introduce a “biosimilar tier,” a low cost–sharing tier that would entice patients to switch to less-expensive biosimilars by using the low-copay carrot approach. This was discussed with patient advocates as well as payers. Plans covering biosimilars, specifically … Continue reading Will a Pharmacy Benefit Design Someday Include a Biosimilar Tier? Not Likely, and Here’s Why →

South Korea–based Celltrion Healthcare announced on April 27 that it has completed its negotiations with AbbVie and that it expects to launch its biosimilar at the same time as the rest of the field—in July 2023. It was the last remaining Abbvie licensing deal to be completed for the Humira® biosimilars. Celltrion’s biosimilar, CT-P17, is … Continue reading And Then There Were None: Celltrion Signs AbbVie Licensing Deal for Its Adalimumab Biosimilar CT-P17 →

Amgen announced on April 18 that its 563-patient study of ABP 654’s efficacy and safety is not demonstrating any clinically meaningful differences compared with the reference product Stelara® in moderate-to-severe plaque psoriasis. The study completion date is scheduled for early June 2022, whereas a multiswitch study is scheduled for completion March 2023. Based on the … Continue reading Preliminary Phase 3 Study Data Looking Good for Amgen’s Ustekinumab Biosimilar →

On March 1, Amneal announced that it had entered the biosimilar market with the FDA approval of its filgrastim biosimilar (Releuko®). On April 14, the company announced another major step on its biosimilar journey: the approval of its second biosimilar, a new version of bevacizumab. Dubbed Alymsys (bevacizumab-maly), the new agent is the third Avastin® … Continue reading Amneal Scores FDA Approval of Alymsys®, a Biosimilar of Bevacizumab →

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight an interesting company based in Singapore. Founded … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: Prestige Biopharma →

What do nanomedicines and biosimilars have in common? Not much, one might think. At the 2022 annual meeting of the Academy of Managed Care Pharmacy, we learned a new term: nanosimilars. John Hertig, PharmD, MS, Associate Professor at Butler University described nanomedicines as complex, non-biologic pharmaceuticals that range up to 1,000 nm in size. They … Continue reading Biosimilar Bytes →

The issues relating to biosimilar misinformation have spurred calls for improving the level of knowledge of practicing healthcare providers. This effort must also seek to educate tomorrow’s healthcare providers about biosimilars today. BR&R spoke with two of the key forces behind the FDA’s important initiative to provide biosimilar education at the schools of medicine, nursing, … Continue reading A Conversation With Sarah Ikenberry and Laura Pincock, Food and Drug Administration on Biosimilar Education in Health Sciences Schools →

The Food and Drug Administration has repeatedly emphasized that biosimilar approvals are based on the “totality of evidence.” However, the agency has emphasized that analytical comparability of biosimilars with reference products comprises by far the most important share of the evidence considered. Phase 3 clinical trial evidence contributes less to biosimilar approval decision making, as … Continue reading It Will Be Difficult to Move Away from Phase 3 Studies for Biosimilar Approvals →

Widespread biosimilar competition at the 30,000-foot level is not without practical complications on the ground. I gained this broader recognition by listening to people who know far more than I do about both biosimilars and its effects on the supply chain. Last week, I was ecstatic to take my first live business trip since the … Continue reading Stocking and Delivering: The Block and Tackle Issues for Adalimumab Biosimilars →

The last of the loose ends have seemingly been tied down, as Alvotech announced on March 8 that it has come to a licensing agreement with AbbVie. The agreement halts remaining patent litigation between the parties, and assumably, pays AbbVie a royalty on sales of AVT02. Alvotech’s adalimumab biosimilar candidate is a high-concentration, citrate-free formulation. … Continue reading Alvotech Signs Agreement With AbbVie; Will Launch in July 2023 if Approved →

The announcement on March 4 that Civica, the private-public partnership among 25 health systems, plans, and foundations, will be producing low-cost insulin in the near future may shake biosimilar insulin competition to its foundations. Skyrocketing insulin prices caught the eye of health providers, advocacy groups, and Congress. This prompted the two main insulin makers, Eli … Continue reading Insulin Wars: Biosimilar Sustainability May Soon Be an Issue With Civica’s Announcement →

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Samsung Bioepis. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: Amneal Pharmaceuticals →

Although Viatris seems to be cashing out its biosimilar portfolio, it is taking a 12% stake in Biocon Biologics as part of a $3.3 billion deal announced with the company February 28. According to Viatris President Rajiv Malik, “Our successful collaboration with Biocon Limited, the majority shareholder of Biocon Biologics, began more than a decade … Continue reading Viatris Sells Its Biosimilar Assets to Partner Biocon for $3.3 Billion →

Pfizer announced on February 25 that the Food and Drug Administration had accepted a supplemental 351(k) application for its adalimumab biosimilar Abrilada™, in an attempt to gain the interchangeability designation. This is just one development in clarifying the upcoming adalimumab interchangeability competition. This press release was posted just before Alvotech’s announcement that the FDA had … Continue reading Adalimumab Interchangeability Competition Coming into Focus →

The simple question of who purchases these biosimilars has the potential to substantially alter the savings associated with biosimilars. A new analysis lays bare the differences in charges associated with provider-purchased biologics compared with specialty pharmacy costs. Frequent readers of this column may recall that I am not completely aligned with published savings estimates associated … Continue reading It May Be Time to Move Beyond Buy-and-Bill to Optimize Biosimilar Savings →

The numbers don’t lie. Companies can profit greatly from the biosimilar business, especially if they get an early jump. Amgen released their 2021 earnings last week, and it tells a compelling story. For fiscal year 2021, Amgen reportedly earned $2.17 billion globally for three marketed biosimilar products. A total of $1.3 billion was earned in … Continue reading Manufacturers See the Upside of Their Biosimilars in 2021 Bottom Lines →

In 2019, Biogen upped its stake in the South Korean biosimilar joint venture, cementing its commitment to biosimilar manufacturing and commercialization. Today, however, Biogen has seemingly reversed course—though it is not exiting the biosimilar arena. In a January 27th press release, Biogen announced that it will sell its 49.9% ownership in Samsung Bioepis to its … Continue reading Biogen Sells Its Biosimilar Stake in Samsung Bioepis, Reaps Handsome Profit →

Natalizumab is one of 20-odd medicines prescribed for patients with the three major forms of multiple sclerosis (MS). Overall, North American revenues for all of the MS medications combined are about $15 billion, which is to say very substantial. With other biosimilar introductions, the reference drugs targeted comprised the majority of prescribing either for that … Continue reading The Interesting Scenario for a Tysabri® Biosimilar for Multiple Sclerosis →

Nichi-Iko Pharmaceuticals offered an update on its plans for its infliximab biosimilar, targeted for the US market. In its latest investor presentation, the company disclosed that it plans to file its 351(k) application in 2023, based on a phase 3 clinical trial, which was completed in 2020. It is in the process of preparing its … Continue reading Biosimilar Bytes →

In an effort to more closely match the options available with AbbVie’s reference product, partners Samsung Bioepis and Organon sent the US Food and Drug Administration a supplemental 351(k) application for a citrate-free, 100-mg/mL form of Hadlima™. The FDA accepted the application, according to the January 5th press release. Hadlima, which was originally approved in … Continue reading Samsung Bioepis Submits Supplemental Application for Citrate-Free, High-Concentration Adalimumab Biosimilar →

The complexity of the insulin competition continues to boggle the mind. On December 17, 2021, Eli Lilly received FDA approval of its Rezvoglar (insulin glargine-aglr), a product that is biosimilar to Sanofi’s Lantus®, and marks the second insulin glargine agent approved this year. Rezvoglar will be available in 3-mL prefilled pens. Basaglar® was the first … Continue reading Second Insulin Biosimilar to Get FDA’s Nod—Eli Lilly’s Rezvoglar™ to Enter the Glargine Market →

On December 20, Coherus Biosciences announced that the Food and Drug Administration approved Yusimry (adalimumab-aqvh). This is Coherus’ second biosimilar approval. In 2017, Coherus completed a randomized, controlled phase 3 study involving 545 patients with moderate-to-severe plaque psoriasis, comparing the biosimilar to the reference product. In addition, the company conducted a pharmacokinetic investigation that confirmed … Continue reading Coherus Secures FDA Approval on Yusimry™, Its Adalimumab Biosimilar →

On December 20, Sandoz announced the filing of its 351(k) application for a new Herceptin® biosimilar. If approved in 2022, it will be the sixth trastuzumab biosimilar competing on the market. Sandoz already markets biosimilar versions of filgrastim (Zarxio®) and pegfilgrastim (Ziextenzo®), and it has received approval for etanercept (Erelzi®, which is not yet marketed … Continue reading Sandoz Sends Trastuzumab Biosimilar Application to FDA →

In August 2020, we posted our findings on the various stages of prospective ustekinumab (Stelara®) biosimilar manufacturers. Since that time, some significant progress has been made by some of the players in this area. Ustekinumab may well be the first interleukin-based biosimilar product entering the market, and its main patent will expire in September 2023. … Continue reading Ustekinumab Biosimilars Update →

Samsung Bioepis’ Eticovo® cannot be marketed in the US until 2029, according to a New Jersey district court ruling. As reported in Big Molecule Watch, the court made a January 2020 temporary stay of marketing final, ruling for the plaintiffs Immunex and Roche. The court reaffirmed that Samsung Bioepis will not be able to sell … Continue reading Biosimilar Bytes →

The earnings reporting season is upon us, and with that comes news about fiscal and nonfiscal progress for individual biosimilar manufacturers. Some news about Amgen’s and Pfizer’s adalimumab biosimilars caught my attention. Amgen’s Interchangeability Play At its third-quarter conference, Amgen announced that it is enrolling patients in a multiple-switching trial in an effort to obtain … Continue reading Amgen, Pfizer Now Seeking Adalimumab Interchangeability, but… →

This interview was conducted at the Drug Information Association’s Biosimilar conference, held virtually October 5–6, 2021. This conversation with Laura Wingate, Executive Vice President of Education, Support, and Advocacy, the Crohn’s & Colitis Foundation, is an edited version of our discussion. BR&R: Laura, what do you think are the key differences, if any exist, between … Continue reading What Do Patients Want to Know About Biosimilars? →

Currently, Amgen’s Neulasta OnPro® holds approximately half the marketshare for the pegfilgrastim category. This on-body injector (OBI) system is deemed more convenient than the conventional prefilled syringe, as patients are not required to travel to the office or clinic for pegfilgrastim administration the day after receiving chemotherapy. This month, Coherus Biosciences announced that its phase … Continue reading Progress on Coherus’ Pegfilgrastim On-Body Injector →

On the heels of Samsung Bioepis’ recent approval of its ranibizumab biosimilar, comes the approval last week of Roche’s new delivery system for the reference product, a product called Susvimo™. The timing is a bit disconcerting, although pretty much everything about age-related wet macular degeneration treatment is disconcerting if not distressing. Susvimo is a follow-on … Continue reading The Ranibizumab Port System: Issues for Patients, Payers, and Biosimilar Makers →

According to a study published in JAMA Internal Medicine this month, the approval and launch of the follow-on insulin glargine product Basaglar turned the tide on rising costs for this long-acting insulin. Approved as a 505(b)2 insulin in August 2014 (prior to the category being transitioned to the 351[k] biosimilar regulatory pathway), Basaglar was the … Continue reading Basaglar® Competition Had a Strong Effect on Insulin Glargine Net Prices →

On October 15, Boehringer Ingelheim formally secured its long-sought adalimumab interchangeability designation from the Food and Drug Administration (FDA). This label was earned based primarily on the results of Boehringer’s VOLTAIRE-X switching studies. The VOLTAIRE-X study demonstrated that patient efficacy or safety outcomes were not affected by multiple switches between Cyltezo and Humira®. Once launched, … Continue reading FDA Designates Boehringer Ingelheim’s Cyltezo® as First Interchangeable Adalimumab Biosimilar →

With the Food and Drug Administration’s (FDA’s) recent approval of the first interchangeable insulin, Viatris and Biocon’s Semglee®, some questions may begin to be answered with respect to payer coverage, automatic substitution, and their potential for success in the marketplace. However, unlike the other biologic drug categories, there are additional levels of complexity among the … Continue reading Insulin Follow-ons, Authorized Generics, Biosimilars, and Interchangeables: A Stew of Competitive Ingredients →

The question of interchangeability for biosimilars has haunted the US Food and Drug Administration since the promulgation of the Biologics Price Competition and Innovation Act of 2010. The FDA’s draft guidelines on interchangeability evolved very slowly, and the biosimilar industry had to work to (1) keep up with the guidelines as they gained clarity, (2) … Continue reading Biosimilar-to-Biosimilar Switching: The Data Say Its Fine →

With the intensity of horse trading that is underway on Capitol Hill, it is difficult to keep up with the latest developments on a number of areas that may affect the biosimilar industry. However, one measure was passed by the House Judiciary Committee on Wednesday with a large bipartisan margin; coupled with Senate clearance by … Continue reading Biosimilar Legislation Making Headway Towards Reconciliation Bill →

Using data from IQVIA, the Amgen Biosimilars Trend Report released this month laid out the latest market data on how biosimilars are faring in the categories outside of insulin. The data emphasize one key trend: Biosimilar competition drives down the average sales price (ASP) of the category; this happens quickly for many categories, even those … Continue reading Here Are Some of the Big Cost Takeaways From the Latest US Biosimilar Data →

Partners Samsung Bioepis and Biogen announced today in a press release that their 351(k) application for its ranibizumab biosimilar (reference product, Lucentis®) gained approval from the Food and Drug Administration. Dubbed Byooviz™, this injectable product is the first biosimilar to be approved for ophthalmologic indications. Formerly referred to as SB11 and now designated ranibizumab-nuna, the … Continue reading Samsung Bioepis and Biogen Register First FDA Approval for Biosimilar Ranibizumab →

Bio-Thera Solutions has partnered with London-based Hikma Pharmaceuticals on its proposed ustekinumab biosimilar BAT2206. The agreement will give exclusive rights to commercialize BAT2206 in the US after FDA approval, with the potential for marketing rights in Europe as well. Although the Hikma Pharmaceuticals USA name is not well known in the US, it does have … Continue reading Commercialization Agreement for Bio-Thera’s Investigational Ustekinumab Biosimilar →

The pegfilgrastim biosimilar story has widely been viewed as a qualified success. The field is a bit crowded: there are four biosimilar competitors, and more to come, in addition to the originator product Neulasta® and Neulasta Onpro® on-body injector. Amgen, the manufacturer of Neulasta, has seen ongoing, decreasing marketshare of the prefilled syringe, but it … Continue reading Pegfilgrastim Prefilled Syringe vs. On-Body Injector: Study Finds no Meaningful Differences in Clinical or Economic Outcomes →

I belong to a local business group where I live in the Philadelphia metropolitan region, and I had the pleasure of speaking to them about my profession. A member of the group asked what topic I most enjoyed covering in the last few years. I drew a breath, and reluctantly answered, “I really enjoy working … Continue reading What Is Important to the Public About Biosimilars? Think Like a Layperson →

On August 5th, partners Formycon AG and Bioeq AG announced that they had completed its new biosimilar ranibizumab application to the Food and Drug Administration, with an eye toward a mid-2022 decision. The US marketer of the product, if approved, will be Coherus Biosciences. The initial application was withdrawn in 2020 because of additional information … Continue reading Formycon and Bioeq Resubmit 351(k) Application →

The search for a mechanism to lower Medicare part B drug prices has been a slow and tortuous journey. The latest detour was announced on Friday by the Centers for Medicare and Medicaid Services (CMS). The most-favored-nations (MFN) proposal, which had gained momentum through December 2020, spurred on by the Trump administration, seems to have … Continue reading Biden Administration Moves Away From the Most-Favored-Nation Drug Pricing Model →

In a long-awaited first, the Food and Drug Administration has approved Viatris’ biosimilar insulin candidate Semglee® as interchangeable, meaning it can be substituted automatically at the pharmacy if the prescription is written for the reference product Lantus®. As allowed by individual state laws, substitution does not require the pharmacy to notify a prescriber. This marks … Continue reading Interchangeability Is Finally a Reality →

The baffling early June decision by the Food and Drug Administration (FDA) to approve Biogen’s Alzheimer’s disease drug and ignore the recommendation of its Advisory Committee has been covered and chronicled to the level of the COVID-19 pandemic. On another platform, I put in my two cents on how payers may step in to save … Continue reading The FDA’s Aducanumab Affair and How It Relates to Biosimilars →

On July 7, the FDA issued a warning letter to Amgen regarding an advertisement it ran promoting Neulasta® OnPro®, its on-body injector version of Neulasta (pegfilgrastim). In the animated advertisement, “the banner makes false or misleading claims and representations about the benefit of Neulasta,” states the letter. “These violations are concerning from a public health … Continue reading Amgen Crosses Biosimilar Misinformation Line, Says FDA →

Held June 22–23, 2021, the American Conference Institute’s 12th annual Biosimilars and Innovator Biologics conference focused on the legal and patent issues affecting the biosimilar industry. In this article, we note some of the takeaways of the presentations. The Year in Review panel focused on recently enacted and proposed legislation. Hans Sauer, Deputy General Counsel … Continue reading An Update on Legislation on Biosimilars and Patents →

The move away from Johnson & Johnson’s originator product has been slow, due to the Pfizer’s flawed launch pricing of its biosimilar, J&J’s actions to defend marketshare, and residual reluctance by gastroenterologists to switch patients whose Crohn’s disease is in remission with Remicade®. According to March data from Bernstein Research, Remicade maintained about 81% marketshare … Continue reading Enticing Patients to Switch to Infliximab Biosimilars →

On June 17, 2021, the US Supreme Court announced its long-awaited decision on the severability of the Affordable Care Act (ACA) from the individual mandate. The Supreme Court sidestepped the basic question, instead ruling 7-2 that the plaintiffs did not have any standing to sue. If the Supreme Court ruling had struck down the ACA, … Continue reading Today’s Supreme Court Decision Saves the US Biosimilar Regulatory Framework →

One of the most obvious components of savings associated with biosimilars is their effect on competition, driving prices down. One of the more overlooked components of biosimilar savings is another characteristic of competition: Once launched, the cost of reference products stop rising. That seems intuitive, but the extent of list price increases for reference biologics … Continue reading Bending the Reference Biologic Price Curve →

On May 20, 2021 Tanvex BioPharma, Inc. issued a press release announcing that the FDA has not approved its 351(k) application for TX01, a biosimilar version of filgrastim. In the announcement, Tanvex cited the FDA’s need to complete manufacturing site inspections, which have been altered by COVID-19 pandemic restrictions. It is unclear whether any additional … Continue reading Tanvex BioPharma Receives Complete Response Letter on Its Filgrastim Biosimilar Application →

Mumbai, India-based Lupin Ltd is attempting to enter the US biosimilar market for the first time with its version of pegfilgrastim. First approved and marketed in India in 2015, Lupin’s pegfilgrastim application was accepted on June 2 by the Food and Drug Administration. The development of this agent included three double-blind, controlled trials, comprising more … Continue reading Lupin’s Pegfilgrastim Biosimilar 351(k) Application Being Evaluated by FDA →

In shared-savings reimbursement models in healthcare, physicians have an incentive to use health resources more efficiently: They may receive bonuses based on the money that they save compared with a benchmark. The accountable care organization model, Medicare shared-savings model, and the oncology care model (OCM) are a few examples. These started as demonstration projects created … Continue reading Are Biosimilars and the Oncology Care Model a Perfect Fit? →

Last week’s AAM Access 2021 virtual meeting generally danced to a positive beat on the progress of biosimilars today and in the near future. In her keynote address, Acting Food and Drug Administration Commission Janet Woodcock, MD, emphasized that the agency’s biosimilar development and consulting program has experienced increasing engagement. Dr. Woodcock stated, “As of … Continue reading Biosimilar Education for Healthcare Professionals →

Last week, Viatris (formerly Mylan) announced during its earnings call that it anticipated that the Food and Drug Administration will provide interchangeability designations to its insulin glargine and insulin aspart candidates when these are approved in July. That could yield a double first—the first biosimilar insulins and interchangeable biosimilars of any type. As reported in … Continue reading Biosimilar Bytes →

In an April 23 press release, Boehringer Ingelheim announced that its phase 3 switching study between its biosimilar Cyltezo® and the reference adalimumab biologic Humira® is complete. The biosimilar maker also stated that it had filed its supplemental application for interchangeability designation with the Food and Drug Administration (FDA). The VOLTAIRE-X study randomized 238 patients … Continue reading Switching Study Complete, Biosimilar Maker Awaits FDA Decision on Interchangeability →

As we inch closer to the January 2023 date for the launch of the first US adalimumab biosimilar, industry watchers are more closely scrutinizing which company, if any, will have a competitive advantage in this lucrative marketplace. Just to reset, the series of settlements signed by AbbVie currently puts Amgen’s Amjevita® first to be released, … Continue reading Further Dissecting the Launch of Adalimumab Biosimilars in the US →

In the past, we have addressed whether the use of the four-letter suffixes have enabled positive identification of biosimilar agents by providers and health plans or simply added to confusion over the quality of the products being prescribed. This issue had faded somewhat, with the realization that the suffixes have been superfluous in identifying which … Continue reading Is Identification of Biosimilars vs. Reference Products Still an Issue? →

If there is anything that Ted Okon, MBA, Executive Director, Community Oncology Alliance, and Peter Bach, MD, from Memorial Sloan Kettering agree upon, it is that hospital systems make more profit by prescribing high-cost drugs than they do with lower-cost agents, like biosimilars. Beyond that, these two wouldn’t be expected to agree on much when … Continue reading Oncology Biosimilars Are Proof That the Market Works →

At last week’s World Biosimilar Congress, much of the content revolved around increasing access to biosimilars. That topic automatically invokes the controversial use of rebate contracting. Robert Popovian, PharmaD, Former Vice President, Govt Relations, Pfizer, asserted that access for oncology biosimilars is much greater than that for infliximab biosimilars because of the latter’s reliance on … Continue reading Biosimilars, Employers, Medicaid, and Rebates →

There may be few areas of the biosimilar industry more frustrating to payers, manufacturers, and observers than the delays in market access due to patent mazes and litigation. Attempts to manage address intellectual property rights of biologic makers ranged from the insertion of the “patent dance” process in the BPCIA to calls for the Federal … Continue reading Mandatory Price Slashing After Biologic Exclusivity Expires: Much Lower Prices but at What Cost? →

A policy paper from the National Comprehensive Cancer Network (NCCN), released in early March, asks payers to refrain from preferring single agents for the treatment of cancer. Based on a survey of cancer center pharmacy directors and policy development by these health executives at NCCN institutions, the white paper expressed concerns particularly around both storage … Continue reading NCCN Biosimilar White Paper Advocates Against Single Preferred Products by Payers →

One of the problems that has stalled greater uptake of biosimilars in the US has been payers’ reluctance to give up their rebate revenue from manufacturers of reference biologics. When payers prefer branded reference agents with higher wholesale acquisition costs (WAC), they retain often substantial rebate revenue, with little benefit to consumers. A proposed bill … Continue reading Forcing Payers to Cover Biosimilars? Beware of Unintended Consequences →

Although big biosimilar news has been lacking in the last couple of weeks, there are several newsbytes that are of interest to industry followers. Here are a few of the more notable biosimilar news items.   The COVID pandemic hadn’t had significant implications for biosimilar developers, but news of a deferred FDA approval decision for … Continue reading Biosimilar Bytes for This Week →

In researching an update on Oncobiologics, an organization that once had an interest in producing biosimilars (adalimumab and bevacizumab), I found a compelling issue that could seriously affect the likelihood of success for several other biosimilar manufacturers. It turned out that Oncobiologics was rebranded Outlook Therapeutics in 2018. At the time, the newly rechristened company … Continue reading Ophthalmology Biosimilars May Face a Formidable Challenger →

A method for government intervention in long-simmering patent disputes on biosimilar medications seems have been hiding in plain sight. And it can be instituted immediately. This is according to a new white paper from New York University School of Law, which highlights a piece of existing legislation that has been on the books for decades … Continue reading Section 1498 May Be a Potential Government Remedy for Approved, Unlaunched Etanercept Biosimilars →

The osteoporosis drug market has evolved markedly since the introduction of the bisphosphonates in 1995. Developed to help prevent bone loss and the complications of bone fracture, and to increase bone mass overall, the market grew to include the selective estrogen receptor modulators in the 2000s, and then biologics in 2010. Amgen’s denosumab (Prolia®), a … Continue reading Denosumab Biosimilar Competitors Gathering Data for February 2025 Launch →

Based on IQVIA’s data on prescription marketshare of biosimilar trastuzumab, bevacizumab, and rituximab, it seems that oncologists are showing little hesitation in adopting these biosimilar products for the active treatment of different cancers. The oncology professional societies, such as the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology, have taken … Continue reading An Oncologist’s Concern About the Biosimilar Use in Real-World Patients With Cancer →

Amgen added another notch on its biosimilar belt last week, receiving approval from the Food and Drug Administration (FDA) to market ABP798, its biosimilar version of Rituxan®. The drug, dubbed Riabni™ (rituximab-arrx), is the third biosimilar rituximab available in the US. It was approved for adult patients with the following indications: Non-Hodgkin’s lymphoma Chronic lymphocytic … Continue reading Amgen Receives FDA Approval for Rituximab Biosimilar Riabni →

Pharmaceuticals companies love direct-to-consumer (DTC) advertising; most television viewers hate it. Advertisements for biologics and small-molecule drugs to treat inflammatory bowel disease, rheumatoid arthritis, cancer, diabetes, HIV, and a host of other disorders come in clusters, targeting news hour and primetime viewers alike. I have nothing against the golfer Phil Mickelson, and I assume he … Continue reading The Limitations of Direct-to-Consumer Advertising for Biosimilars →

By the time 2020 ends in a couple of short weeks, the US Food and Drug Administration (FDA) will have made decisions on the fate of at least two proposed biosimilars. In addition, a few manufacturers have announced plans to complete the 351(k) application process by the end of the year. Based on our current … Continue reading Biosimilar Company Updates: Tanvex, Bio-Thera, and Coherus →

F. Randy Vogenberg, PhD This week, veteran employer benefit consultant F. Randy Vogenberg, PhD, RPh, writes about how the Supreme Court’s upcoming decision in State of Texas v. USA can affect self-funded and fully funded employers and how they need to prepare for its ramifications. There seems to be a common interest in lowering the high costs … Continue reading Supreme Court Deliberations on the ACA: Impact on Employers’ Biosimilar Strategy →

Last week, the Trump administration issued an interim final rule that would allow Medicare to obtain far lower pricing on a specific list of high-cost part B pharmaceuticals. A reading of the text of the most-favored nation (MFN) rule, which evolved directly from Congress’s 2019 proposal to fix the price of 250 medications to an … Continue reading Many More Questions Than Answers in Medicare’s Most-Favored Nation Interim Final Rule →

It will take a close reading of the 600 pages of government policy to grasp their implications, but it seems the final rules by the Department of Health and Human Services (HHS) could on one hand lower a real barrier to biosimilar uptake and on the other hand create real problems for biosimilar manufacturers. In … Continue reading The Medicare Part D Rebate Rule and Biosimilars →

Samsung Biologics announced in its third quarter earnings report that they and partner Astra Zeneca have agreed to shut down their joint venture Archigen Biotech. This news was first reported in the Korea Biomedical Review. Archigen was created in 2014 with the hope of developing a biosimilar to reference product Rituxan/MabThera for the treatment of … Continue reading Archigen Closes Its Doors After Failing to Introduce Rituximab Biosimilar →

Since 2014, when Zarxio® was the first biosimilar product approved by the Food and Drug Administration, manufacturers have seemed attuned to the need to two aspects of the launch: (1) pricing and (2) service offerings. Payers, for example, assumed that the net cost of biosimilars would be lower than the reference product assumption (the question … Continue reading Wraparound Services: Biosimilar Makers Must Be Sure to Get Them Right →

On November 18, Samsung Bioepis and its marketing partner Biogen jointly announced that the 351(k) application for SB11, a ranibizumab biosimilar, has been filed and accepted by the Food and Drug Administration. The US patent for Roche’s reference product Lucentis® expired in June 2020, and the market for ranibizumab could be over $1 billion. Lucentis … Continue reading Samsung Bioepis’ Ranibizumab Biosimilar Application Filed With FDA →

Of the several pieces of legislation floating in the netherworld of Congressional action (or inaction) is the bill that was introduced by Senators John Cornyn (R-TX) and Michael Bennet (D-CO) early this past summer. Entitled the Increasing Access to Biosimilars Act of 2020, it directs the Centers for Medicare and Medicaid Innovation to create a … Continue reading Thoughts on the Savings From a Biosimilar Shared-Savings Model →

Until the onset of COVID-19 pandemic, employers sponsored the health plans that covered 49.6% of the US population. “Although the situation is very fluid,” F. Randy Vogenberg, PhD, RPh, Board Chair of the Employer–Provider Interface Council (EPIC), told BR&R, “a conservative estimate is that this may have dropped closer to 40% at one point with … Continue reading Employers Getting Their Arms Around Biosimilars, but Will Push Come to Shove? →

The results of an interesting study of infliximab biosimilar use at a Veterans Administration (VA) facility were announced at the Academy of Managed Care Pharmacy’s Nexus 2020 session. The paper outlined real-world experience that further bolsters support for biosimilar infliximab switching.   The poster did not indicate industry support for the research. It detailed changes … Continue reading Physician Familiarity Fuels Infliximab Switches to Biosimilar →

Although it appears today that biosimilars for Enbrel® will not be launched before 2029, a budget impact analysis presented at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting hints at how much money is being left on the table until then. Researchers from Xcenda and Sandoz (the latter of which has an approved etanercept … Continue reading Missed Opportunity for Huge Savings With Biosimilar Etanercept →

How do payers and health systems view the barriers to biosimilar adoption in October 2020? A survey by the Academy of Managed Care Pharmacy (AMCP), the AMCP Foundation, and its partners revealed the latest views of a group of healthcare stakeholders.1 The poster presented at last week’s Academy of Managed Care Pharmacy’s (AMCP) Nexus meeting … Continue reading Pharmacists Believe Lack of Interchangeability Information and Designations Pose Real Barrier to Biosimilar Adoption →

The sessions from the Drug Information Association Biosimilars 2020 virtual meeting held earlier this month touched on some very important points for the biosimilar community. In addition to our previous meeting report, I thought some others needed to be mentioned briefly, with a bit of commentary. One Biosimilar Class That Poses Difficulties for Comparative Pharmacokinetic … Continue reading Biosimilar Bytes from DIA Biosimilars 2020 →

Much of the discussion around biosimilars recently, including at the DIA Biosimilars conference held last week, involved the necessity of phase 3 trials. More precisely, this published and on-line activity addressed how best to streamline the biosimilar development process. The discussion has been ongoing for several years now, as not all biosimilar 351(k) applications have … Continue reading Biosimilar Clinical Trial Costs in Terms of Expense and Time →

With the requirements of social distancing and new protocols for working off-site, the COVID-19 pandemic has affected nearly all sectors of business to some extent. Even if it has not greatly affected revenues, it has inarguably affected how we conduct our businesses. The overall effect on the ability of the US Food and Drug Administration … Continue reading The FDA’s View of the COVID-19 Pandemic’s Effect on Biosimilar Development →

In just a few years, the biosimilar sales in the US will outpace those in the EU, according to a consultant speaking at ACI’s 11th Summit on Biosimilars and Innovator Biologics last week. This will be likely driven by a single biosimilar, and you can probably guess which one. The EU is not a monolithic … Continue reading US Biosimilar Market Will Soon Catch up to the EU →

Its intent was to improve tracking and reportability, but the Food and Drug Administration’s decision to employ four-letter suffixes for biosimilars may have created its own misleading information. This would be truly ironic, considering FDA’s own efforts to restrict or eliminate misleading information that could deter biosimilar utilization. New evidence has been published recently that … Continue reading Four-Letter Suffixes May Be FDA’s Own Brand of Misleading Information on Biosimilars →

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight an interesting company based in Sydney, Australia. … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: NeuClone →

One of two biologics injected intravitreally to treat forms of macular degeneration, edema, or retinopathy, Eylea® (aflibercept) was first approved by the US Food and Drug Administration (FDA) on November 18, 2011. Originally approved as a single-dose vial, its manufacturer, Regeneron, received FDA approval of a prefilled syringe in December 2019. We covered the potential … Continue reading Who Are the Key Aflibercept Biosimilar Players to Watch? →

The biosimilar news streaming over the past couple of weeks has been interesting, with an important update of a crucial story to the biosimilar field. We commented on some of the more noteworthy items below. Date Set for Supreme Court Arguments in ACA November 10 is the date now set by the US Supreme Court … Continue reading Biosimilar Bytes →

This week, we asked veteran employer benefit advisor and consultant F. Randy Vogenberg, PhD, RPh, to write about the employer’s role in encouraging the use of biosimilars. Dr. Vogenbergs’ recent work with business coalitions and individual employers around the management of the medical or drug benefit, and specialty pharmaceuticals in particular, allows him to address … Continue reading Employers, Biosimilars, and Pharmaceutical Benefits: Something’s Gotta Give →

To date, prospective biosimilar makers have had plenty of chances to hone their business skills. They have calculated opportunity costs, projected constantly updated financial projections, worked their legal departments and partners overtime, and tested new communication skills with the FDA. Among the factors that manufacturers have to address when deciding on new biosimilar targets: patent … Continue reading The Next-Generation Biosimilar Race: A Tale of Two Autoimmune Biologics →

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies with products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight the European manufacturer Alvotech. The drug maker has … Continue reading A Profile of a Lesser-Known Player in the Biosimilar Space: Alvotech →

The presence of misleading information on biosimilars, along with outright false statements, continues to pester the biosimilar industry. This situation repeats the marketing efforts of branded medications in the 1980s as it attempted to fight off the insurgence of generic drugs. And it is very important to note that there are still, 35 years later, … Continue reading Delving into Misleading or Disparaging Information on Biosimilars →

On July 24, 2020, we still await the first FDA-designated interchangeable biosimilar. This may not be a surprise: All of the biosimilars launched to date are administered in the physician’s office, hospital, or outpatient clinic. Without pharmacy distribution, there can be no automatic substitution, the prize at the end of this journey. The last time … Continue reading Interchangeability, Switching, and What Happens Next →

On July 6, the Food and Drug Administration approved partners Mylan/Fujifilm Kyowa Kirin Biologics’ biosimilar version of adalimumab for use in patients with autoimmune diseases. Officially dubbed Hulio® (adalimumab-fkjp), this 28th approved biosimilar will be first available for prescription in August 2023, based on the licensing deal Mylan signed previously, making it the fourth adalimumab … Continue reading Adalimumab Biosimilar Approval for Mylan and Fujifilm Kyowa Kirin →

Shared-savings programs have been used by the Centers for Medicare and Medicaid Innovation (CMMI) to leverage financial incentives for providers into lower costs for Medicare. In the last 2 months, this idea has been floated to improve access to biosimilars–a biosimilar shared-savings program for Medicare Part B. There is ample evidence that biosimilars in general … Continue reading Biosimilars and Shared-Savings Programs →

Multiple biosimilars may have launched in a particular category, but this does not lessen the financial risk of a biosimilar manufacturer who has not settled (or cleared) their patent litigation. The recent filing by Genentech against Samsung Bioepis’ proposed Avastin® biosimilar, SB8, serves as a reminder. The June 28th filing of Genentech v. Samsung Bioepis, … Continue reading Bevacizumab Biosimilar Launch and Development Still a Risky Proposition →

On July 1, a US Appeals Court sided with Amgen, maker of Enbrel®, in patent litigation against biosimilar maker Sandoz. This is a source of continuing frustration for payers, health systems, and perhaps most of all, patients. Will this product be effectively shielded from competition for 31 years? Sandoz’s Erelzi® was approved in 2016, but … Continue reading Biosimilar Etanercept: Amgen’s Victory in Federal Appeals Court Further Delays Launch →

Will biosimilar manufacturers and patient access somehow benefit from the COVID-19 pandemic? I am having some trouble following the logic of those who believe it will. If people who cannot afford their medications when economic conditions decline, they may not be in a better situation to afford biosimilar versions of biologic medications, especially if their … Continue reading COVID-19 Pandemic Is not Necessarily an Opportunity for Biosimilars →

As reported by several sources, Amgen and eculizumab maker Alexion Pharmaceuticals have come to an agreement on patent disputes that will allow Amgen to begin marketing a biosimilar version of Soliris® in 2025. Amgen has been developing ABP 959 for some time, and a phase 3 clinical trial in patients with paroxysmal nocturnal hemoglobinuria (PNH) … Continue reading Amgen Settles With Alexion on Soliris Biosimilar, Dropping Litigation and Getting a Release Date →

Lannett, a maker of generic pharmaceutical products, disclosed that it has been in talks with the Food and Drug Administration (FDA) about bringing a biosimilar version of insulin glargine into clinical trials. March 22, 2020 marked the transition of new insulin agents from being considered a 351(a) biologic to a 351(k) biosimilar. Few manufacturers have … Continue reading New Entrant into Insulin Market Wants to File as Biosimilar in 2022 →

Although Mylan and partner Biocon did not beat the March 22, 2020 deadline for the transition of new insulins to biosimilar status, they were able to secure a 505(b)2 FDA approval for their insulin glargine follow-on agent. On June 11, the partners announced receiving FDA approval for Semglee™. Technically, Semglee has the same amino acid … Continue reading Mylan/Biocon’s Insulin Drug Saga Ends With an Approval →

The ranks of the pegfilgrastim biosimilar competition is filling out, with the latest approval by the Food and Drug Administration. Pfizer announced the approval of its product Nyvepria™ on June 11. Officially designated pegfilgrastim-apgf, Pfizer has not yet announced a launch date for this agent. However, in its press release, Andy Schmeltz, Global President, Pfizer … Continue reading Pfizer’s Pegfilgrastim Biosimilar Approved by the FDA →

At the recent virtual conference of the International Society of Pharmacoeconomic and Outcomes Research, two budget impact models were presented in an effort to demonstrate potentially sizable benefits of biosimilar coverage by health plans. The studies were supported by Pfizer, manufacturer of the two biosimilars in question (Zirabev® and Ruxience®). Both were authored by the … Continue reading Budget Impact Modeling: Good Information but Don’t Take Them Literally →

A joint press release from Mylan and Revance issued on June 1, 2020 stated that progress is being made on characterizing a proposed Botox biosimilar. As a result, Mylan has agreed that the onabotulinumtoxinA biosimilar development program should proceed. According to the press release, the partners engaged the Food and Drug Administration to discuss the … Continue reading The Botox® Cure: Biosimilar OnabotulinumtoxinA Development Moves Ahead →

A research letter that appeared in JAMA in May has been receiving attention in biosimilar and payer circles. The attention may be a bit outsized compared with the importance of the authors’ findings, but they do support an important point: Biosimilars cannot succeed without payer coverage. The good news is that payers do cover biosimilars … Continue reading Health Plans Still Utilize Fail-First Policies for Some Biosimilars →

As the battle lines become better drawn for the next wave of biosimilar applications and approvals, ranibizumab is getting a lot of attention lately. The patent on Roche’s reference product Lucentis® is due to expire in 2022, and this drug earned approximately $1.8 billion in revenue in 2019. On May 18, Samsung Bioepis announced continued … Continue reading Samsung Bioepis Announces Interim Phase 3 Study Results for Ranibizumab Biosimilar →

The question of replacing reference drug therapy with a biosimilar goes to the heart of provider confidence in attaining equivalent patient outcomes using the latter. There is relatively little resistance today in starting new patients with a biosimilar if there is a convincing economic case for it. Switching treatment in patients whose conditions are stable … Continue reading Biosimilar Switching: The Evidence on Its Utility and Safety Keeps Rolling in →

Over the course of several years, BR&R has followed the progress of several smaller biopharmaceutical firms, each of which have (or had) plans to enter the US market. In this post, we update developments for several of these manufacturers below. Tanvex Biopharma USA. When we first reported on Tanvex in October 2018, it had just … Continue reading Updates on Some Lesser-Known Manufacturers’ Plans for Biosimilars in the US →

In April 2020, Americans have ample reason to worry about their health and welfare. The COVID-19 pandemic has turned upside down the economic climate of this country within 6 weeks, with longer-term effects that we can only begin to calculate. One of the effects that has been on everyone’s minds is how this affects access … Continue reading Prescription Abandonment and the Economic Effects of COVID-19 →

Very little is comparable between the US and Europe in terms of biosimilar approval, launch, and market penetration, but the latest data from Ronny Gal, PhD and his team at Bernstein Research make it possible to do a snapshot review of the two major markets. The statistics paint an encouraging picture of increasing biosimilar penetration … Continue reading An Interesting Comparison: The Latest Data on US and EU Biosimilar Uptake →

This morning, Merck issued a press statement to announce that it had joined the trastuzumab biosimilar fray, with the launch of Ontruzant®, which was developed by its partner Samsung Bioepis. This marks the fifth biosimilar to Herceptin® that has become available for prescription. However, the retail price or wholesale acquisition cost (WAC) price is approximately … Continue reading Partners Merck and Samsung Bioepis Launch Fifth Trastuzumab Biosimilar →

Unless the pharmaceutical rebate is applied at the time patient cost sharing is calculated, there may be no patient incentive to ask for a biosimilar. It’s all in the timing of the drug rebate. Consider the scenario in which a patient with inflammatory bowel disease is prescribed infliximab by the doctor. Let’s use Health Affairs … Continue reading Patient Cost-Sharing “Advantage” Can Only Exist in a Biosimilar World Without Rebates →

A study was recently published in the Journal of Managed Care and Specialty Pharmacy that evaluated the clinical results and economic benefits of a switch to biosimilar infliximab (specifically Inflectra) compared with the reference product Remicade® in adult patients with inflammatory bowel disease (IBD). The savings accrued from the widespread use of biosimilars has been … Continue reading One Academic Medical Center’s Clinical Experience and Savings With Biosimilar Infliximab →

On Monday, March 23, biologic products formerly evaluated for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are now approvable only under section 351 of the Public Health Service Act (PHS Act). That means many categories of drugs will now be considered eligible for biosimilar competition. The transition date … Continue reading Transition Day for Insulins, Other Products →

We had the opportunity to speak with Christine Simmon, the public face of an organization that has long championed the biosimilar industry. Our conversation covered topics from the worst-case scenario in the State of Texas v. USA to oncology biosimilar uptake and AAM’s current priorities. Biosimilars Review & Report: What’s the one thing about the … Continue reading A Conversation With Christine M. Simmon, Executive Director, Biosimilars Council and Senior VP, Policy and Strategic Alliances, Association for Accessible Medicines →

Approved in 2018, Herzuma® is hitting the market, announced Teva and Celltrion. Teva, which is marketing the trastuzumab biosimilar in the US and Canada, will begin offering the biosimilar at a wholesale acquisition cost (WAC) of 10% below that of the reference biologic Herceptin®. In a press release, Brendan O’Grady, Executive Vice President of Teva’s … Continue reading Partners Teva and Celltrion Announce Launch of Herzuma →

At the World Biosimilars Congress this month, we had the opportunity to sit down with Dr. Leah Christl, formerly one of the key scientists at the FDA’s Center for Drug Evaluation and Research. She was “present at the creation” of the FDA’s biosimilar approval pathway and in 2019 moved into her current position at Amgen. … Continue reading A Conversation With Leah Christl, PhD, Executive Director, Global Regulatory and R&D Policy at Amgen →

The Canadian provinces have begun to line up behind automatic substitution of biosimilar infliximab for Remicade®, after the announcement of British Columbia’s policy change in May 2019. Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada, offered some background into the decision on biosimilar switching at the World Biosimilar Congress on March 2 … Continue reading The Plan That Convinced Canada to Switch to Biosimilars →

Several weeks ago, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced plans to collaborate to manage and restrict misleading information on biosimilars being disseminated by reference manufacturers. This messaging, designed solely to place doubt into the mind of patients, providers, and payers, is considered to be a significant obstacle to … Continue reading The FDA/FTC Workshop: Beginning to Address Misleading Biosimilar Information →

In its recent earnings call discussing fourth-quarter 2019 results, Mylan disclosed that the US Food and Drug Administration (FDA) accepted its 351(k) application for a potential new bevacizumab biosimilar. The application was submitted in the late fourth quarter of last year and was not publicized through Mylan’s communications department. The agent, MYL-1402O, had been subject … Continue reading Mylan Reports FDA Submission for Bevacizumab Biosimilar →

After a flurry of action in December and January, there has been comparatively little action on the biosimilar news front in the past couple of weeks. As a result, I was looking forward to refreshing the till with a visit to the World Biosimilars Congress 2020 in San Diego this week. And the meeting didn’t … Continue reading 26/15/9: Biosimilars at the Crossroads →

In the last year or so, the crystal ball for biosimilar sustainability has become less cloudy. That is only to say that with approvals and launches of some biosimilars, we have a better understanding of the factors that will define viability of the American marketplace. It seems that, for certain drug categories at least, biosimilar … Continue reading Taking the Long View on Biosimilar Markets →

On February 5, Merck announced that it will create a new spinoff that will include its biosimilar business with Samsung Bioepis as well as its legacy pharmaceuticals (e.g., Zetia®, Vytorin®, and other widely diversified brands). In its press release, Merck emphasized that the as-yet unnamed new company will also have a strong focus on women’s … Continue reading Merck to Spin Off Company That Will Include Its Biosimilar Marketing in 2021 →

The journal Arthritis & Rheumatism published an article in January explaining that the use of infliximab biosimilars for the treatment of rheumatoid arthritis is “flatlining.” It probably didn’t take a pharmacoeconomist and rheumatologist to understand why this has happened. Those familiar with the biosimilar environment know well that infliximab biosimilar utilization has been stagnant since … Continue reading Lack of Penetration of Infliximab Biosimilars: Is This News? →

A press release from the US Food and Drug Administration and the Federal Trade Commission announced the signing of a joint statement that focuses on anticompetitive behavior in the biosimilar market. According to the FDA and FTC, this statement describes “key steps the agencies will take to address false or misleading promotion about biosimilars within … Continue reading FDA and FTC Say They Will Work Collaboratively to Deter Anticompetitive Behavior →

Activity on Pfizer’s biosimilar front has been electric over the past couple of months, as it executes its launch plan for three biosimilar monoclonal antibodies to treat cancer. In December, the company launched its bevacizumab biosimilar Zirabev®, and on January 23, Pfizer announced the availability of its rituximab biosimilar Ruxience®. Ruxience is the second launched … Continue reading Pfizer Launches Ruxience, Announces Pricing for Upcoming Trazimera →

With the announcement that Pfizer has formally launched its bevacizumab biosimilar Zirabev®, the next logical question is how the price compares with the competition—Roche’s brand Avastin® and Amgen’s biosimilar Mvasi® that are already available. At Pfizer’s stated pricing of $61.34 for a 10-mg vial, this represents a 23% discount to the reference product’s wholesale acquisition … Continue reading Bevacizumab ASP Pricing now Dropping With Biosimilar Entries →

Note: This is an update to a January 2020 post to include Lupin’s investigational agent in phase 3 trials. Roche’s reference product Lucentis® (ranibizumab) seems to be the next likely target for biosimilar competition. Sales of the drug in the US were last reported to be $1.5 billion in 2017, but Roche’s revenues from Lucentis … Continue reading Who Are the Key Lucentis Biosimilar Players to Watch? →

Innovent Biologics (Suzhou) Co., Ltd., based in China, signed an agreement on January 13, 2020 that allows Coherus Biosciences to commercialize its bevacizumab biosimilar when approved by Canadian and American regulators. The investigational agent is known as IB1305 at present. Recently completing a phase 3 trial with Chinese patients, Innovent will need to gather the … Continue reading A US–China Partnership: Coherus Biosciences Will Market Chinese Biosimilar Maker’s Avastin Biosimilar in North America →

On January 2, 2020, Spectrum Pharmaceuticals announced that the FDA had accepted its 351(a) application for a novel granulocyte colony-stimulating factor (G-CSF), eflapegrastim. And no, the name is not misspelled here; the name is a close cousin of pegfilgrastim. As reported in 2018 by the Center for Biosimilars, this agent showed promise versus pegfilgrastim. As … Continue reading And Now for Something Completely Different… Eflapegrastim vs. Pegfilgrastim →

The year 2020 has gotten off to a flying start—probably a direct consequence of 2019 finishing with a flurry. One of the first eye-catching bits of news was the request by several states for the Supreme Court to intervene now, not later, in the case that threatens the fundamental basis on which the biosimilar pathway … Continue reading Will the Supreme Court Fast Forward Health Insurance Reform in 2020? →

Closing out the week before the holidays, the House and Senate’s Appropriations Bill specified two significant passages that affect the March 22, 2020 transition date for insulins being approved under the 351(k) pathway. Here’s a summary of these two points. A TWEAK TO THE BIOSIMILAR INSULIN QUESTION On December 17, 2019, two Food and Drug … Continue reading The Appropriations Bill Alters Insulin Biosimilar Rules →