Tag: biosimilars

The Second Entyvio Biosimilar Is Under Review at FDA

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 accepted by both the FDA and the EMA for PB016, a proposed vedolizumab biosimilar candidate to Entyvio lyophilized vial for intravenous administration.

PB016, in-licensed from Polpharma Biologics S.A., is a proposed biosimilar to IV vedolizumab, an integrin-receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease in adults.

vedolizumab biosimilar

“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”

The first biosimilar biologic licensing application was submitted in June by Alvotech and Teva.

In Other Biosimilar News

Amneal closed on its purchase of Kashiv Biosciences, a deal which “combines Kashiv’s biologics research, development and manufacturing capabilities with Amneal’s commercial scale, establishing biosimilars as a major long-term growth pillar within the Company’s Affordable Medicines business.” 

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

MFP Agreements Don’t Guarantee Better Patient Access

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 in January 2026.

One of the main stipulations of the MFP agreements was that if the reference drug manufacturer signed an MFP agreement, Medicare Part D drug plans and Medicare Advantage plans would have to cover the drug on their formularies.

Enbrel and Stelara Rejection Rates

Enbrel and Stelara are the two Part D drugs of interest in this first round of Medicare MFP negotiations. Enbrel has no current biosimilar competition (though 2 approved products), and Stelara has plenty of it.

These two drugs comprise the immunology sector of the first 10 drugs subject to MFP. According to the IQVIA data, the initial rejection rates for those new to the brand were 59% for the first quarter of 2026. When looking forward 30 days, the average rejection rate on appeal was 22%. In the past 5 years, the initial rejection rates ranged from 61% to 73%. IQVIA did not break down the rejection rates for the two individual biologics.

In their post, IQVIA said, “Expectations for Medicare drug price negotiation to improve patient access have yet to come to fruition. Even more concerning, additional future IPAY-selected drugs are in the immunology and oncology therapeutic areas and other therapeutic areas with similar costs and treatment complexity, facing similarly high levels of payer control.”

The Result of Heavy Biosimilar Competition?

Granted, both etanercept and ustekinumab are unusual products, in that they are both subject to heavy competition from other agents within the same or similar drug categories. In fact, the MFP for Stelara is not competitive with several ustekinumab biosimilars on the market today. The existence of over 10 adalimumab biosimilars at deep discounts would be a highly attractive prior step before approval of either Enbrel or Stelara. Therefore, it is unlikely that payers will significantly change coverage policies to improve access to these two agents under current conditions.

As more Part B medications are subject to MFP negotiations, patient access may change somewhat for those particular drugs. However, one must remember that patient access improvement was not the primary goal of Medicare MFP negotiations under the Inflation Reduction Act. The real goal was cost reduction for the Centers for Medicare & Medicaid Services.

As we can see, cost reduction may not equal better patient access, even if deep price reductions on biologics are available on direct-to-consumer sites because of relatively high patient out-of-pocket costs. Therefore, this finding is not surprising. We saw the same lack of effect when the adalimumab biosimilars were first introduced in 2023: Much lower costs didn’t result in prescriptions to patients; only formulary policy changes did.

Instead, I tend to view IQVIA’s study as more supportive of a 360-degree view of the effectiveness of biosimilar competition for these two medications.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

Are Biosimilar Patient Copay Assistance Programs Lacking?

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 competition has driven average sales prices (ASPs) on the medical side by more than 60% for products available for at least three years. This ranges from epoetin alfa at -37% to rituximab at –81%. On the pharmacy benefit side, adalimumab wholesale acquisition costs are down more than 80% for most product offerings relative to the original cost of Humira.

Biosimilar Patient Copay Assistance Programs

Success in driving down costs also means less net revenue earned from individual products. This could influence the willingness of manufacturers and their commercialization partners to offer a suite of services to patients and physicians through financial assistance programs and hub programs for handling prior authorization and reimbursement coding questions.

Even at these great discounts, the monthly copay costs to patients would be hard to bear and may be unsustainable for some extended periods of time. I have reported on this problem with respect to direct-to-consumer access for specialty brands and biosimilars. It is the reason why patient copay assistance programs are so widespread across the pharmaceutical industry, particularly for expensive biologics.

Most in the biosimilar business had considered a robust patient copay assistance program and hub services program, matching that of the reference manufacturer, to be the cost of entering the market. The reference product generally had multiple service offerings to maximize prescriber comfort to optimize utilization of their products. If physicians, who sometimes rely on this suite of services, were given a choice of a lower-cost biosimilar with fewer services and the standard reference product offering, it would make them less willing to adopt the biosimilar.

In the last couple of years, I’ve been made aware of some rumblings in the provider community that manufacturers were in fact cutting back on their biosimilar patient copay assistance programs and hub services offerings. In a market research project I worked on for an upcoming publication, some dermatologists, rheumatologists, and neurologists brought up this perception, particularly for patient copay assistance programs. As a result, BR&R conducted a quick survey of manufacturers, based on their website resources, of their biosimilar copay assistance programs.

For standardization purposes, we assumed an adequate program to be one resulting in monthly copays of $5 or less for commercially insured patients, independent of the duration of access to the program. Of course, the overall impact does not consider copay maximizers or copay accumulators from health plans.

How Many Manufacturers Don’t Have Biosimilar Patient Copay Assistance Programs?

As of July 24, a total of 68 biosimilars were marketed; we counted denosumab biosimilars as a single molecule, despite having two brand names. We then removed insulin biosimilars from the survey: They each offer a form of copay assistance, with $35 monthly copay limits. Much of this was the result of government pressure. That brings the number of eligible surveyed biosimilars down to 63. Eight or 13% were without copay assistance programs. There were some interesting caveats for those lacking these packages.

Recent Biosimilar Launches

It takes many months to fully develop a launch plan for any pharmaceutical. Generally, a product launch would not occur if all the ancillary services were not in place and ready for immediate use. For Biocon Biologics, which launched its denosumab biosimilars (Bosaya/Aukelso) in April 2026, its website indicated that its patient copay assistance program would be “coming soon.” Gedeon Richter and Hikma’s denosumab biosimilars Enoby and Xtrenbo were launched in January this year, but do not any copay assistance program associated with them.

Bio-Thera Solutions’ bevacizumab biosimilar Avzivi likewise does not have a patient assistance program. Its commercialization partner, Sandoz, does not list it among its Sandoz One offerings.

Bio-Thera and its commercialization partner Hikma do not have a copay assistance program for its Starjemza ustekinumab biosimilar. It is the only ustekinumab program lacking copay assistance.  

Low-Cost Products

Nypozi, a filgrastim biosimilar by Tanvex BioPharma and commercialized by Cipla for more than 6 months, has no such services listed. Pfizer does not list a patient assistance program for Retacrit, its epoetin biosimilar. These are the least costly drug categories (outside of insulin) overall. The ASP for epoetin products is approximately $7 per 1000 units. For filgrastim, prices for the three least expensive biosimilars are $107 to $133 per 480 mg.

Discontinued Programs 

In only two cases did a program exist but be discontinued. For Boehringer Ingelheim’s Cyltezo, the program ended July 15, 2026. Quallent, which sells a private-label version of this adalimumab biosimilar, claims to have a copay assistance program, but the website listed only terms and conditions, without an opportunity to enroll. Perhaps, this is in the process of rolling out in the transition. Until then, it is the only adalimumab biosimilar without a copay assistance program.

Byooviz is Samsung Bioepis’ ranibizumab biosimilar, originally in partnership with Biogen. Biogen included Byooviz in its patient assistance offerings, until the partnership ended. Harrow took over US commercialization for the biosimilar but has not unveiled a patient copay assistance program for it.

What About the Private-Label Biosimilars?

The private-label distributors add an interesting aspect to the mix, as we do not count their products as separate from the biosimilar parent. Yet, there is some interesting nuance in this area.

For example, OptumRx’s specialty distributor Nuvaila has a separate site for adalimumab-atto’s copay assistance, but it links back to Amgen’s own patient assistance site. Patients needing copay assistance for another adalimumab, Sandoz’s Hyrimoz, can access it through the Sandoz One Source, but the private-label version through Cordavis also has its own website. Finally, Cordavis, which also distributes a private-label version of Samsung Bioepis’ Hadlima, offers patient copay assistance, as does Samsung’s marketing partner for Hadlima, Organon. As mentioned above, Quallent also claims to offer such a program for its Simlandi private label (Teva provides one for the Simlandi brand), but this seems to be a terms sheet without access to online enrollment.

The Take Aways

Generally, the marketed biosimilars have patient copay assistance programs but the greatest variability seems to be associated with companies recently entering the US market or where product costs are the lowest.

Only 13% of marketed biosimilars are currently without qualified patient assistance packages. In terms of these financial assistance programs, physicians who believe that biosimilars manufacturers are lacking these offerings seem to be off base. We do not know if they are similarly incorrect about other services, like eligibility verification, prior authorization assistance, and handling returns. We may investigate the availability of these hub services in the future.

A slew of new biosimilars are expected to be launched in the next 12 months, including those in the aflibercept, denosumab, golimumab, omalizumab, and pertuzumab categories. We’ll have to watch closely.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.

Tracking Two Bills to Remove the Clinical Efficacy Study Requirement for Biosimilar Development

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 could be paired with a similar proposal just reaching Senate Committee discussion. Both of these proposals seek to reduce the cost of biosimilar development through squeezing out the need for comparative efficacy studies.

Expedited Access to Biosimilars Act

As reported earlier, the FDA in October 2025 announced a draft guidance that would achieve the same end, to remove the mandate for late-stage clinical efficacy trials for biosimilar manufacturers. However, a final guidance has not yet been released.

Introduced by Representatives Nick Langworthy (R-NY) and Kim Schrier, MD (D-WA), the Expedited Access to Biosimilars Act (HR 9661) could codify long-awaited regulatory changes to comparative trial expectations in the 351(k) biosimilar pathway.

According to a press release from Congressman Langworthy’s office, the act would eliminate unnecessary regulatory hurdles while preserving the FDA’s authority to require additional studies whenever scientifically warranted. This supports the October 2025 announcement of a draft guidance for removal of a mandate for phase 3 clinical efficacy studies for biosimilars. A key stipulation of the proposal would be a requirement for FDA to notify manufacturers early in the review process if additional late-stage comparative efficacy studies will be required. The aim would be to provide greater certainty around the clinical trial resources required for a successful biosimilar application process as well as avoiding unnecessary delays in the application process.

A number of associations have express support for the legislation including the Association for Accessible Medicines, the American Society of Health-System Pharmacists, and America’s Health Insurance Plans, among others.

The Senate’s 2025 Proposal

A Senate proposal by the same name (S.1414), introduced in April 2025 by Senator Rand Paul (R-KY), seeks largely the same goals. It has languished in the Committee on Health, Education, Labor, and Pensions, without additional cosponsors, until now. A committee meeting is scheduled for July 22 to finally consider this legislative proposal. It has one co-sponsor (Sen. Mike Lee, R-UT).

We’ll be monitoring whether the Expedited Access to Biosimilars Act can break through for an eventual debate and vote on either the House or Senate floor.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.

Biosimilar Bytes: Golimumab Patent Litigation, Positive Keytruda Biosimilar Trial Results

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 to Janssen, 14 patents each are at issue on its reference products Simponi and Simponi Aria.

Janssen BIotech v Alvotech patent litigation

Alvotech and its commercialization partner Teva resubmitted its 351(k) application for approval of ATV05 on June 4. It is not known why Janssen did not file the BPCIA patent suit once Alvotech first sent its biologic licensing application to the FDA in January 2025.

Bio-Thera Solutions and its marketing partner Accord BioPharm received the first FDA approval for golimumab biosimilars on May 15, 2026. Of course, they are also in the midst of patent litigation with Janssen to prevent a delay in marketing of this biosimilar as well. Janssen first filed its complaint in March 2026, involving 17 patents. In response, Bio-Thera filed for Inter Partes Review on 4 patents involving methods of treatment, while claiming the others were either obvious or publicly available. According to Big Molecule Watch, a District Court hearing is scheduled for September 1. The principal patents on Simponi have already expired. Accord BioPharm had previously announced an expected launch later this year.

Samsung Bioepis’ SB27 Phase 3 Results

Despite several other prospective pembrolizumab biosimilar makers foregoing or discontinuing phase 3 trials, Samsung Bioepis has plowed forward, announcing preliminary positive results for its investigational product SB27.

Although the phase 1 and phase 3 trials are not yet completed, the initial results announced indicated equivalent pharmacokinetic data for SB27 compared with the reference product Keytruda, as well as clinically similar outcomes (i.e., objective response rates) in the double-blind, parallel-group, phase 3 investigation at week 24.

The FDA announced last October that late-stage clinical trials will no longer be routinely required for biosimilar development and approval. Most manufacturers pulled the plug on ongoing or planned trials for pembrolizumab biosimilars, as we reported in November.

Samsung reported that it expects to complete both the phase 1 and phase 3 trials by the end of 2026.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.

When is a Biosimilar a Biosimilar?

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 a biosimilar the same worldwide?

You may suspect that the answer is obvious, but then again, why are we asking it? Is it a trick question? Years ago, the answer was not so simple. Those of us covering the biosimilar field in the 2010s will recall that some Indian companies, for example, were producing what might be considered “follow-on” medicines by the FDA’s regulatory standards, but were promoting them as biosimilars.

No Guidances by FDA on Follow-on vs. Biosimilar Products

Global biosimilar regulation

The FDA’s own regulatory definition was not set in stone: Basaglar, the second insulin glargine product to receive FDA approval, is a biosimilar but technically not a biosimilar. Even today, there may be some confusion as to whether Basaglar is considered a biosimilar or a follow-on product. It was indeed approved by the FDA under a 505(b)2 application, principally because insulins were not considered eligible for the 351(k) approval pathway until 2020. The FDA would probably support that it is clinically equivalent to Lantus in any way that matters. Yet, from a regulatory perspective, it was not evaluated as part of the biosimilar pathway, so it cannot be designated a biosimilar.

The same can be said for Granix, the second filgrastim product approved by the FDA, which underwent its approval process before the 351(k) was implemented (and under which Zarxio was licensed). It is important to note that the FDA itself has not tried to improve clarity by announcing retrospectively that these agents can be considered either biosimilar or an equivalent.

A Survey of Biosimilar Definitions

So, is a biosimilar a biosimilar throughout the world? An article published in JAMA Health Forum described a survey of 19 countries’ biosimilar regulatory guidelines. These included 12 with emerging and developing economies and 7 with advanced economies, according to the World Health Organization classification. The authors, from the University of San Francisco and GlaxoSmithKline, found that most countries define “biosimilarity as the absence of differences in the medicine’s quality, safety, and efficacy compared with the RP. Sixteen countries explicitly required comparability exercises to demonstrate biosimilarity, and 13 countries specified that the same RP must be used in these studies.

“Of the 19 countries in the study sample, 17 (89%) have adopted the WHO’s biosimilar terminology; the exceptions were Indonesia, which uses the term follow-on biological in addition to biosimilar, and Tanzania, which uses the term similar biotherapeutic product. A total of 17 countries (89%; except India and South Korea) define biosimilarity according to the absence of differences in quality, safety, and efficacy between the biosimilar and the reference product, although in some countries (Egypt, Turkey, UK, and US), this is heavily implied rather than explicitly stated. Most countries (n = 16 [84%]) require comparability exercises (by definition), but 3 (Mexico, Indonesia, and China) do not explicitly include this requirement.”

The authors also stated that all advanced economies waived the need for clinical efficacy and immunogenicity testing when justifiable, but guidelines from emerging and developing economies differed on clinical study waivers.”

Interestingly, one of the areas of least consensus is that of biosimilar naming and labeling guidance provided. Countries such as France, Germany, Japan, and South Korea do not specify any requirements, whereas the UK, US, and Canada do, among the WHO advanced economic sector. Among countries in the emerging and developing economic region, China and Mexico do have naming and labeling guidelines, whereas Brazil, India, and Indonesia do not. The area of greatest agreement seemed to be in acceptance of extrapolation, with all but Saudi Arabia among the surveyed countries with published extrapolation guidelines.

Scoping surveys such as this are necessary steps in a march towards global regulatory standards for biosimilars. They show not only how far we’ve come in reaching basic agreements, but also how far we need to go. Perhaps, most importantly, they show us areas where a push for global standards would have the least likelihood of success.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.

Alvotech Submits First Entyvio Biosimilar Application to FDA

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 Entyvio. This marks the first FDA 351(k) drug application for a vedolizumab biosimilar.

vedolizumab biosimilar, Entyvio biosimilar

In its press release, Joseph McClellan, Chief Operating Officer  of Alvotech, stated, “FDA acceptance of the BLA for AVT16 is another important step in advancing our mission to increase access to biologic medicines for patients worldwide. Our proposed interchangeable biosimilar to Entyvio builds on our experience in immunology and reflects the strength of our fully integrated development and manufacturing platform.”

Vedolizumab, an integrin-receptor antagonist, is currently approved to treat adults with moderate-to-severe ulcerative colitis and Crohn’s disease. The reference product is available in both intravenous infusion and subcutaneous injections.

Takeda’s US Entyvio net revenues were over $4 billion in 2024, but the biologic has been targeted for Medicare maximum fair price negotiation. The negotiated price will be implemented on January 1, 2028, unless biosimilar launch is imminent. The original drug patent is set to expire in 2026.

Intravenous Infusion vs. Subcutaneous Injection

AVT16 would be available only as an intravenous infusion. Alvotech’s biologic licensing application does not cover the subcutaneous injectable. A separate investigational product, AVT80, promises a biosimilar version of the prefilled syringe and autoinjector administration. Alvotech noted that the European Medicines Agency has received a marketing application for both AVT16 and AVT80. It is not clear whether Alvotech and its marketing partner Teva, intends to market these products under separate brand names if approved. The patent on the subcutaneous formulation may not expire until the 2030s, according to some sources, which may play into Alvotech’s decision to separate the FDA applications.

In Other Alvotech Biosimilar News  

In November 2025, Alvotech received complete response letters from the FDA on two products—its biosimilar versions of golimumab and aflibercept. On June 4, 2026, the biosimilar manufacturer revealed that it had resubmitted its 351(k) applications to the FDA for both products (AVT05 for golimumab and AVT06 for aflibercept). Alvotech noted that it expects an FDA decision within 6 months. The complete response letters cited production facility issues, and not data or clinical quality questions. The latest FDA surveillance inspection of the Reykjavik production facility was completed by May 11, according to the company.  

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.

How Comfortable Are Neurologists With Biosimilar Prescribing?

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.    

Biosimilar prescribing by neurologists

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. The effort to educate specialists around the safety and efficacy of the biosimilar(s) may take time. In the past, manufacturers of the reference products countered competition with misleading marketing efforts to preserve their revenues. To cite just two examples, this occurred with gastroenterologists with the introduction of infliximab and with ophthalmologists with the launch of the first ranibizumab biosimilar. And then of course, there was the slow acceptance of adalimumab, based on different formulations.

Last October, the natalizumab biosimilar Tyruko was launched by Sandoz, primarily for the treatment of multiple sclerosis. Will neurologists’ biosimilar prescribing follow this stunted path? Only if you think natalizumab marks the first foray of biosimilars into the field of neurology medicine. In reality, this is not the case.

Eculizumab and Rituximab Biosimilars in the Neurology Toolbox

One reason that neurologists’ biosimilar prescribing will be quicker is that natalizumab is actually the third biosimilar used by these specialists. Eculizumab is usesd to treat patients with the neurological condition generalized myasthenia gravis. That drug has been available as a biosimilar since March 2025.

Although many neurologists have moved from the eculizumab reference drug Soliris to the follow-on brand Ultomiris, the appearance of biosimilars has likely exposed them to more prior authorization and/or step therapy, encouraging the use of lower-cost eculizumab biosimilars. Additionally, their experience with buy-and-bill eculizumab biosimilars gave them a brief preview of buy-and-bill reimbursement for the natalizumab biosimilar.

Another factor impacting neurologists’ biosimilar prescribing is not so obvious: A significant portion have been prescribing rituximab and its biosimilars off label to treat some neurologic disorders, including myasthenia gravis, multiple sclerosis, and neuromyelitis optica spectrum disorder. And rituximab biosimilars were approved since 2018.

Neurologists May Be More Comfortable With Biosimilars Than You Think

In working on a survey of 40 practicing neurologists for a biosimilar manufacturer and marketer, it became apparent that the respondents were far more familiar with biosimilars than we may have assumed.

In the case of the present survey, which was conducted just before the launch of Tyruko, 41% of the neurology sample had indicated they had experience with rituximab biosimilar prescribing s within the previous 12 months. This may have contributed to the view by 40% of the sample that the use of either eculizumab or natalizumab biosimilars would not have any effect on their practice. An additional 22% believed the biosimilars might actually result in greater profits. This should certainly make it easier for makers of biosimilar forms of market-leading Ocrevus, when they are launched in 2028.

Watch for further insights from this survey project in the next month, once the full results are published.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.

A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. 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 updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market.

Why you may be hearing more about this company: Formycon has two principal biosimilar targets, ranibizumab and ustekinumab. The company disclosed that “it successfully completed a Type IV pre-submission meeting with the US Food and Drug Administration (FDA) in December 2018 and clarified other pivotal issues. The filing with the FDA for the approval of FYB201 is expected at the beginning of the fourth quarter of this year.” A filing for the European Medicines Agency is planned for 2020. A phase 3 clinical trial of this agent was completed in June 2018. In the development of this agent, Formycon partnered with Bioeq GmbH, but it is unclear whether a marketing partner exists for a possible US launch.

The patent for ustekinumab (Stelara®) expires in 2023 (US) and 2024 (Europe). It is partnered with Aristo Pharma GmbH on the manufacture and testing of this interleukin 12/23 inhibitor (also known as FYB 202).

Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of Eylea® (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.

In other biosimilar news… Amgen decided to pull its EMA application for its infliximab biosimilar, likely due to market competition. The company has not taken similar action with regard to an FDA application for the same product, ABP 710. Considering that neither Samsung Bioepis or Pfizer failed to gain traction in the US marketplace for infliximab, Amgen must think that some biosimilar infliximab marketshare growth in the US is still possible.

The Baby, Biosimilars, and the Bath Water

You’ve heard the expression, “throwing the baby out with the bath water.” It refers to the problem of unintended consequences of our actions.

On December 14, Texas District Court Judge Reed O’Connor decided that when he ruled that the individual mandate of the Patient Protection and Affordable Care Act (ACA) is unconstitutional, the entire Act is also invalid. If affirmed, this doomsday scenario may well mean that all of the provisions of the Act are to be repealed.

Texas District Court
Texas District Court Judge Reed O’Connor

One crucial piece of legislation incorporated into the ACA is the BPCIA—the Biologics Price Competition and Innovation Act, on which the biosimilar regulatory pathway is founded. Yes, if the appeals are upheld and the US Supreme Court affirms the decision, the last 7 years of progress made in creating a competitive environment for biosimilars could be jeopardized.

SEVERAL PROGRAMS AT RISK, INCLUDING BIOSIMILAR REGULATIONS

President Trump has stated to reporters that he was happy with the decision of the Texas District Court and hopes that the Supreme Court will not overturn it. His perspective might be different if he thought through the full implications of the action. The repeal will directly affect the 17 million people who receive their health insurance through the ACA, either through the exchanges or expansion of state Medicaid programs.

The unintended consequences of a full repeal of the ACA without any comparable replacement will affect not only work done in biosimilar development and regulation in the US, but also by the Centers for Medicare and Medicaid Innovation (i.e., accountable care organizations and value-based contracting) but closing the Medicare part D coverage gap, the Patient-Centered Outcomes Research Institute (to conduct comparative-effectiveness research), and work done to advance prevention in public health.

In fact, many of the provisions of the ACA are supported by broad consensus. For one, discriminating against people with preexisting conditions, through either exclusions or higher rates. Although the Republicans have not credibly defended this concept by their past actions, they do profess to believe in it.

The potential benefits of a value-based health system is another area where all political parties seem to agree. Hope springs eternal that outcomes-based payments, reimbursements that include shared savings, and bundled or global contracts will improve our care quality and efficiency.

A CONSENSUS ON THE BIOSIMILAR PRESENT AND THE BIOSIMILAR PROMISE

Those who understand the intent of the BPCIA believes that it will result in significantly lower drug costs, at least in the long term. A spokesperson for the Association for Affordable Medicines told BR&R in an E-mail, “As Congress and the Courts respond to last week’s ruling, it’s important to remember that the biosimilars pathway remains one of the least controversial aspects of the Affordable Care Act. All stakeholders agree on the need to maintain this critical aspect of the law. Without it, patient access to biosimilar medicines would be jeopardized.”

tEXAS dISTRICT cOURT

Just last week, the trade association America’s Health Insurance Plans applauded the Trump administration for releasing draft guidances that begin moving transitional drugs to biosimilar status in 2020 and for its efforts to reduce biologic drug pricing in general.

Of course, a number of reasonable scenarios may yet occur to prevent the loss of our baby. The Texas District Court ruling may be overturned on appeal, the Supreme Court may overturn it outright, or the Supreme Court may apply it specifically to the individual mandate (allowing all other ACA provisions to remain). The process has already begun—attorneys general from 17 states filed on December 17 for an expedited appeal by the Fifth Circuit Court of Appeals.

The Trump administration has staked much on its promises to improve drug access and lower pharmaceutical costs. However, the President’s positive comments on District Court ruling directly conflict with the actions of the Department of Health and Human Services (e.g., Secretary Alex Azar and FDA Commissioner Scott Gottlieb).

If the worst-case scenario comes true, which I personally believe is unlikely, will new legislation have to be proposed and enacted to preserve our ability to evaluate and approve biosimilar agents? Will the FDA be prohibited, in the meantime, from progressing with existing biosimilar drug reviews? These questions must be considered, because our ideas of what is realistic are being sorely tested. This baby’s health must be protected from this ruling’s unintended consequences.