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 be two biosimilars that have been publicly announced as targets, as well as an option for 4 more biosimilar candidates.
Kyung-Ah Kim
For the two specific biosimilar candidates covered by the announcement—Fasenra (benralizumab)andIlaris (canakinumab)— Samsung will be responsible for development, regulatory processes, and manufacturing, and Teva will commercialize the products. The biosimilar candidate for benralizumab is designated SB41; the reference product is a maintenance treatment for patients with severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophil syndrome. The Ilaris biosimilar candidate is designated SB44; Ilaris is an interleukin-1 beta agent approved for the treatment of Still’s disease, gout flares, and periodic fever syndromes.
Samsung Bioepis and Teva have already teamed up on the FDA-approved eculizumab biosimilar Epysqli. “We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis.
Richard Francis, President and CEO of Teva said, “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the US.”
In addition to Teva, Samsung Bioepis had signed agreements with several marketers, including Organon (selling Renflexis, for example), Sandoz (for Pyzchiva and up to 5 biosimilar candidates), and Harrow (for Opuviz and Byooviz),
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.
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 the 351(k) pathway for biosimilar candidates and the 505(b)2 pathway for small molecules?
Biosimilar-Type Products Already Approved Through the 505(b)2 Pathway
The 505(b)2 pathway was used for some products that are considered by most as biosimilars today. For example, Basaglar, the first copy of insulin glargine, was approved in 2015 through this pathway; it was before insulins transferred to the biosimilar pathway for approval in 2020. Admelog was the first insulin lispro copy, approved in 2017 through the 505(b)2 pathway as well. However, Granix, the first filgrastim molecule launched that was not Epogen or Procrit, utilized the 351(a) pathway, meant for innovator biologics; it predated the implementation of the 351(k) route to approval.
With streamlining of biosimilar development—a major focus of regulators today—it makes sense to wonder if the 505(b)2 pathway is a valid goal for biosimilar manufacturers.
The 505(b)2 application pathway was implemented through the Hatch–Waxman Amendments of 1984. It was not meant as an abbreviated pathway for generics, but rather a streamlined way to bring new forms of existing innovative medications to market. These are commonly referred to as “follow-on” products. The basis for its use is that the innovator product on which the follow-on molecule is based has a truckload of patient experience proving its safety and efficacy. The manufacturer would simply have to show that its product was very much like the innovator. Its application could range from new formulations, strengths, to other modifications that wouldn’t be expected to affect the structure or anticipated effectiveness.
According to Drug Patent Watch, development cost of a 505(b)2 product might be anywhere from $8 million to $20 million, and the timeline to reach the market (not counting patent litigation) could be as short as 3 years. The 505(b)2 pathway allows a manufacturer to utilize the innovator product’s preclinical and clinical data, requiring little more than comparability studies and bridging pharmacokinetic studies to reach the FDA application stage. The FDA may still require a phase 3 trial, which would change the costs dramatically, but it appears attractive in any case.
Of course, biosimilars require a bit more consideration, as they are far more complex than small molecules, for which the 505(b)2 pathway was intended. With the push to streamline biosimilar development, including waiving the phase 3 trial mandate, eliminate separate testing for interchangeability (and eliminate the designation itself), and drop the need for bridging studies, it is not difficult to visualize movement in this direction.
The Difference With Insulin as a Biosimilar
Yet, insulin is a relatively simple biologic molecule. It has decades of use and clinical experience supporting its safety and efficacy. When the 505(b)2 pathway was used to approve Basaglar and Admelog, few considered this a big risk (it may have helped that the first biosimilars were already approved and in clinical use).
Biosimilars are not follow-on products, unlike typical 505(b)2 agents. Rather, biosimilar manufacturers strive to make their candidates as close a copy as possible to the innovator (but realizing an exact match is impossible). Logically, it might seem that the biosimilar approval process should be at the same level of proof as the 505(b)2 pathway. No, that can never be the case—the structure of biosimilars will always be a little different than the innovator agent. And the structure will always change a bit over time (as will the innovator biologic).
It is better, instead, that the 351(k) pathway is modified to reflect the real-life experience of the biosimilars approved to date by the FDA and the EMA, and that does provide ample opportunity for lowering the bar, and costs, of development.
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.
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 manufacturers are reticent about giving too much information about their pipeline—possibly because of concerns of competitive intelligence or deals in the works—Sandoz has a list of 26 active biosimilar programs publicly disclosed on its website but says there are up to 39 candidates in the Sandoz biosimilar pipeline today. For context, only some of these biosimilar candidates are based on their own research and development. Whereas in the earlier days of the US biosimilar market, Sandoz was the sole force behind the commercialization of the first biosimilar approved in the US, Zarxio, and the first denosumab approved in the US, Jubbonti/Wyost, Ziextenzo (pegfilgrastim), and Enzeevu, an aflibercept biosimilar. It has focused more recently on being a marketing partner to other biosimilar manufacturers. This includes partnerships with Polpharm (e.g., Tyruko), Samsung Bioepis (e.g., Pyzchiva), Bio-Thera Solutions (e.g., Avzivi), Henlius (e.g., Erbitux), Formycon AG (e.g., Cimerli), and Eirgenix (e.g., Perjeta).
That is not to say it is not involved in biosimilar R&D today; on September 8, Sandoz announced its new “Bio100” initiative. With Bio100, Sandoz intends “to have more than 100 biosimilars in the portfolio by 2040, from a current total of 13.” In its press release, the company says it will nearly “double current [loss of exclusivity] coverage to around 80% from 2035 onwards.” In simpler terms, this means that the company seeks to have pipeline products for nearly 80% of biologics that have lost exclusivity by 2035. That could also mean that it will be looking more broadly at the products that are stuck in the biosimilar void today.
Look no further than the sales estimate for the reference products being targeted at the moment: the range is from $2 billion for several products to $31 billion for Keytruda. Of course, these net sales figures may be affected by both most favored nations agreements and future Medicare Maximum Fair Price (MFP) negotiations. The most powerful inducement to biosimilar development will always be potential profits; although this is a fact of life, of the 26 candidates in the Sandoz biosimilar pipeline, none of which would necessarily be considered part of the biosimilar void. One of the issues with the biosimilar void is that although patents on these biologics may have expired, net sales revenues are generally below $1 billion.
That is not true of the planned pipeline for its Bio100 initiative. Sandoz identified a multitude of patent expiration opportunities that coincide with lower-revenue products. With streamlining of the biosimilar development process, the company hopes that the associated reduced development costs will produce biosimilar candidates in this lower range of revenues.
Presently, Sandoz has some rare disease targets in its sights. The 2026 Sandoz biosimilar pipeline lists lanadelmumab (Takhzyro), efgartigimod alfa (Vyvgart), and ravulizumab (Ultomiris) in early development (reference product net sales, $2 billion, $8 billion, and $12 billion, respectively).
Furthermore, Sandoz is seeking to fortify its multiple sclerosis portfolio with the addition of a biosimilar ocrelizumab (Ocrevus), which is prescribed far more often than either its biosimilar Tyruko or the reference product Tysabri.
The next generation of immunology products are well represented on Sandoz’s pipeline, including early-stage research on guselkumab (Tremfya), vedolizumab (Entyvio), risankizumab (Skyrizi), and dupilumab (Dupixent).
Evolocumab (Repatha) is Amgen’s first-in-class PCSK9 inhibitor, and Henlius has a product in preclinical development. Should it ultimately be approved by the FDA, Sandoz will have commercialization rights in the US.
Adding to its ophthalmology biosimilar aspirations is an early-stage candidate for faricimab (Vabysmo), in addition to the forementioned aflibercept and marketed Cimerli products.
However, the company’s greatest current focus is on the oncology products Opdivo, Keytruda, Erbitux, Yervoy, Darzalex, Padcev, and Tecentriq. This is in addition to advanced formulations of trastuzumab (antibody–drug conjugate) and Opdivo (SC version).
Additional Biosimilar Products on the Radar
Luspatercept is an injectable erythroid maturation agent used to treat severe anemia associated with beta thalassemia and myelodysplastic syndromes.
Tezepelumab is a biologic used to treat severe asthma and chronic rhinosinusitis.
Burosumab is an injectable that is approved for the treatment of X-linked hypophosphatemia (XLH) and fibroblast growth factor 23–related hypophosphatemia in tumor-induced osteomalacia. This agent would complement its existing denosumab osteoporosis biosimilar.
Sotatercept is an activin-signaling inhibitor for the treatment of pulmonary arterial hypertension.
Anifrolumab is a biologic used as an add-on to standard therapy for patients with moderate-to-severe systemic lupus erythematosus. Also, Sandoz has a biosimilar candidate that it hopes will compete with Benylsta, the popular agent used to treat SLE (as a marketing partner to Henlius).
In-House Development vs. Partnerships vs. Both
The Bio100 announcement also emphasized Sandoz’s intent to focus on in-house development of biosimilars while also using partnerships to grow out the pipeline. Whereas currently, Sandoz has averaged about 2 biosimilars entering in-house development each year, it hopes to increase this number to 7 by 2035, and as many as 10 per year in 2040. Partnerships, with Sandoz as co-developers and/or marketers for other manufacturers, will be needed to fill out the broader expectations of Bio100 biosimilar candidates by 2040.
Postscript: On September 21, Sandoz announced a new partnership with mAbxience to commercialize a new biosimilar candidate (emicizumab, reference name, Hemlibra) outside of certain South American countries. The main patent on this drug, a bispecific compound to treat hemophilia A, should expire around 2032.
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.
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 of Yesafili in the United States is an important milestone in our efforts to improve access to high-quality biosimilar medicines. It strengthens our presence in ophthalmology and reflects our commitment to making advanced treatments more accessible and affordable for patients around the world.”
Biocon Biologics Logo
The second aflibercept biosimilar has reached the US market, as Biocon Biologics announced the launch of Yesafili. Initially approved in May 2024, along with a slew of other aflibercept biosimilars, launches were delayed by settlement agreements with the manufacturer of the reference product, Eylea.
Pricing information was not reported for Yesafili. Significant sales volume of the first marketed aflibercept biosimilar, Pavblu, was achieved with a relatively small wholesale acquisition cost discount (–16%). Amgen, in its second-quarter 2026 earnings, reported $280 million in US sales, putting it on pace to be the first billion-dollar biosimilar. It has largely driven Amgen’s overall biosimilar revenues, which are up 29% from the same quarter in 2025.
Dr. Reddy’s Readying Rituximab Biosimilar for Launch with Fresenius Kabi After FDA Approval
On August 1, 2026, Dr. Reddy’s Laboratories received FDA approval for its rituximab biosimilar. The brand name and nonproprietary name suffix were not announced at the time of posting.
Dr. Reddy’s entered into a commercialization agreement with Fresenius Kabi to market the monoclonal antibody biosimilar in the United States.
The agent was known as DRL_RI in clinical trials, is already commercialized in the European Union in the United Kingdom. It is sold under the brand name Ituxredi in those markets. A launch date has not been announced for this fourth rituximab biosimilar approved by the FDA.
Currently, two biosimilars (Truxima and Ruxience) lead the rituximab category, each with 35% market share by volume, based on IQVIA data.
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 1, 2026, Medicare-negotiated prices for the first set of targeted drugs went into effect. Among these products was Enbrel (etanercept), the only drug on this list with impending biosimilar competition. Although biosimilar competition in this category will not be introduced until 2028, the maximum fair price (MFP) program will threaten manufacturers of etanercept biosimilars as well as other biosimilar makers.
Amgen Continues to See Enbrel Sales Decline
In reporting its 2026 first-quarter earnings, Amgen indicated a 37% drop in Enbrel sales revenue compared with the first quarter of 2025. In its press release, Amgen stated, “The decline in net selling price reflects the impact of US Medicare part D price setting under the Inflation Reduction Act…as well as increased 340B program mix.” We assume that this also considers increased catastrophic benefit liability for the manufacturer owing to part D redesign.
None of this is surprising: Amgen has reported lower net sales revenues for Enbrel every year since 2020. Nearly all of its Enbrel sales revenue is US-based. Three etanercept biosimilars have been sold in Europe for more than 6 years, and Pfizer holds commercial rights to Enbrel outside of North America. It reported Enbrel sales revenues of $627 million in 2025, which is also 9% lower than in 2024).
This continuing downward trend in the US is likely the result of several factors: (1) heavy competition from other branded anti-TNF agents and interleukins, (2) lower-priced biosimilar competition in the adalimumab and ustekinumab categories, (3) the recently implemented MFP pricing, and (4) other market factors (e.g., 340B mix of sales, part D redesign).
The MFP Effect: A 67% Discount on Enbrel and What It Means Down the Road for Biosimilar Makers
The lower MFP price for Enbrel, which is 67% below the previous WAC price, does result in lower net selling price for Amgen and thus lower revenues. We just don’t know how much it contributed to Enbrel’s first-quarter sales decline.
Overall, this spells worrisome news for the two currently approved etanercept biosimilars (by Samsung Bioepis and Sandoz). It likely means that whatever market shares the biosimilar manufacturers can attain when they do launch, it will be worth significantly less in total revenue dollars than they initially anticipated. If we extrapolate the sales figures from the first quarter to the full year, total 2026 US revenue for Enbrel will be approximately $1.3 billion. Based on continuing revenue declines (not necessarily from prescription volume declines), this figure can easily dip below the $1 billion mark (i.e., the definition of a blockbuster drug) by the end of the year.
Because of the multiple factors affecting Amgen’s Enbrel earnings, it may not provide the best evidence to support biosimilar manufacturers’ fears about the Inflation Reduction Act, reported earlier. Yet it does make sense that the MFP will lower sales expectations for biologics that were (or are) considered targets for biosimilar competition. This will make the decision to spend R&D resources on those prospective biosimilars less enticing.
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.
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 article. This was intentional. I have made the decision that the interchangeability designation is immaterial to a biosimilar’s acceptance by providers, uptake by plans, or both, and am no longer reporting whether the designation has been awarded. This will include use of the designation in our biosimilar database, by the end of this year.
Over many years, I have written and talked to anyone who might read or listen that the FDA’s interchangeability designation is a confusing, failed attempt to make biosimilars more accessible and to ease their way into the market.
Early on, the misperception gained traction, likely perpetuated by some manufacturers, that a biosimilar subjected to more testing as part of the approval process was actually a better product than a noninterchangeable biosimilar. It’s not a crazy notion; it’s just wrong. One can argue that despite the FDA’s efforts to dispel this idea, it still exists in lesser-informed circles. The fact remains: An interchangeable biosimilar is not more efficacious, safer, or higher quality than another biosimilar. Period.
Interchangeability for Automatic Substitution by the Pharmacy
The original intent in the BPCIA was simple: The biosimilar interchangeability designation was solely to allow automatic substitution by pharmacies of the interchangeable biosimilar for the reference product. Nothing more. Yet, automatic substitution has been employed to increase biosimilar adoption in only a couple of isolated instances. In fact, the FDA itself confused the issue, by applying the designation to some products that were not distributed by pharmacies, most notably ranibizumab biosimilars. The reason for this was never elucidated. I suspect that the manufacturer applied for the designation, and the FDA complied, perhaps thinking this buy-and-bill drug may sometimes be white-bagged through a specialty pharmacy. Let’s just say that it didn’t help the manufacturer, based on its anemic market share. In fact, interchangeable biosimilars have not led the way in uptake for any eligible drug categories.
The FDA itself has indicated that its current philosophy is that all biosimilars that receive approval should be considered interchangeable with the reference product. It just hasn’t codified this into regulation yet. The agency simply removed the requirement for additional switching studies to earn the biosimilar interchangeability designation.
Interchangeability Among Biosimilars
A greater, practical issue remains unaddressed by the FDA: The question of interchangeability with other biosimilars has never progressed. The FDA fell back on the regulatory guidelines, saying that one biosimilar was never tested to be interchangeable with another biosimilar. However, real-life practice by plans and PBMs with changing formularies have freely covered one biosimilar over another, with subsequently modifying their coverages annually, without any reported safety concerns or significant loss of efficacy. In other words, there is no clinical issue when substituting one biosimilar for another, much less for a reference product.
Several initiatives have been introduced to finally erase the biosimilar interchangeability designation or at least to neuter it. The Red Tape Elimination Act is one example, as was expunging it from the budget during the Biden Administration.
If someone in the payer or pharmacy space has actually leveraged the interchangeability designation to improve biosimilar uptake, I’d like to hear about it. Until I hear about a significant case, I’ll refrain from reporting on biosimilar interchangeability, except for its ultimate demise.
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.
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) for the reference products Simponi and Simponi Aria, respectively. Commercialized in the US by Accord Biopharma, Immgolis was developed and manufactured by Bio-Thera Solutions. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.
Immgolis is approved for the treatment of severely active rheumatoid arthritis (RA), in combination with methotrexate, and for the treatment of moderately to severely active ulcerative colitis. The Immgolis Intri formulation is approved only for adults with moderately to severely active RA in combination with methotrexate. This does not represent the full set of indications of the reference product, as Simponi is also indicated for the treatment of active psoriatic arthritis alone, or in combination with methotrexate and active ankylosing spondylitis.
“As the first golimumab biosimilars approved in the US, Immgolis and Immgolis Intri represent a meaningful new option for people in the US who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” stated Chrys Kokino, President of Accord North America, in the company’s press release. He added, “This approval answers a clear demand in the US market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030.” Launch is expected by Accord BioPharma in the fourth quarter of 2026.
The outlook for biosimilar competition in this category is somewhat limited, in that there has been only one other publicly disclosed golimumab biosimilar. That product, AVT05, is produced by Alvotech and will be commercialized by Teva postapproval. Its initial 351(k) application was accepted by the FDA in January 2025, but the drug makers were issued a complete response letter for manufacturing issues in November 2025.
Golimumab is a TNF inhibitor, and Immgolis will compete against not only the other biosimilar TNF competitors (e.g., adalimumab and infliximab) and their low net prices, but with the approved interleukin biosimilars (e.g., ustekinumab) as well for the same autoimmune indications.
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.
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.
CVS Caremark clarified to BR&R that its Cordavis private-label version of Samsung Bioepis’ Pyzchiva would be preferred, as well as the original branded Yesintek from Biocon, and not the original branded version of Pyzchiva.
Pyzchiva’s wholesale acquisition cost (WAC) (both he branded and private-label version) is 85%–86% below the original WAC price of Stelara (which is now available at a 75% discount). CVS Caremark stated that there will be $0 consumer cost sharing when either of the two preferred biosimilars are prescribed.
Joshua Fredell, PharmD, Senior Vice President, CVS Health, said, “Expanding adoption of FDA approved biosimilars allows us to deliver significant savings for clients while supporting broader, more affordable access to proven therapies.”
In addition, CVS Caremark noted that the biosimilars Tyruko (reference product, Tysabri) and Epysqli (reference product, Soliris) will also be covered. CVS did not disclose that these two reference products would be excluded from coverage, however. Unlike ustekinumab, natalizumab and eculizumab, are most commonly covered under the medical benefit.
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.
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 instance, the FDA suffered massive staff cuts under the auspices of Elon Musk’s DOGE and was forced to hire back many of the same people.
Former FDA Commissioner Dr. Marty Makary
Meetings of FDA’s Advisory Committees have been few and far between. This essentially wiped out the public’s ability to comment directly to scientists at the time of their votes for recommending or denying a particular drug approval. In fact, several of the FDA Advisory Committees no longer meet at all; only four meetings were scheduled to occur this year through the end of this month.
A Legacy of Advancing Biosimilar Development?
The FDA under Dr. Makary seemed eager to move forward to streamline biosimilar development, but this has not yet resulted in finalized regulatory policy. It is true that under his watch, the FDA issued its draft guidance on the removal of the mandate for phase 3 trials in biosimilar development, but 7 months later, no finalized guidance has been issued. During this time, the FDA has seemingly implemented this rule in any case, and as reported earlier in 2026, several biosimilar manufacturers have acted upon it, by terminating active phase 3 investigations.
In addition, we still have no official policy that nullifies or overrides the infamous interchangeability designation, despite FDA’s expressed opinion that it should be applied to any approved biosimilar, and holding a workshop on the issue last September.
In March, a draft guidance was released on removing the need for bridging studies when non-US licensed reference products are used for pharmacokinetic studies. The timing of the finalized document (after a public comment period) is up in the air, and may be further delayed without an official FDA Commissioner in office.
At certain points, he seemed to embrace the chaos at HHS and at others he tried to tamp down fires caused by the administration. In the end, his decision to fight industry interests in their promotion of flavored E-cigarettes may have been his undoing. However, it seems unlikely that anyone can truly make a lasting impression at FDA after only 13 months.
Overall, a statement he made at last October’s GRx+Biosims meeting sums up his legacy: “I think that we can unite in this country by focusing around health.” It demonstrated either the impossible challenge he faced in the administration or extreme obliviousness regarding the serious attacks on US public health by his boss at Health and Human Services.
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.
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 Amneal had previously purchased a subsidiary of Kashiv (Kashiv Specialty Pharmaceuticals) in 2021, it announced on April 22 that it intends to purchase 100% of the parent company.
According to Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal, “With Kashiv, Amneal becomes a fully integrated global biosimilars leader at the forefront of the next wave of U.S. affordable medicines. This acquisition is a natural next step in our strategy to build a leading, diversified biopharmaceutical company, and we are confident it will drive accelerated growth and long-term value creation.”
As part of the deal, Amneal will obtain two US production plants and two India-based production facilities.
The $1.1 billion transaction includes $375 million in cash at closing, along with $375 million of equity. Kashiv will also receive up to $350 million in potential payments upon attaining specific regulatory milestones, in addition to royalties on its products. Amneal expects that the acquisition will close before the end of 2026.
Organon to Be Sold to Sun Pharma for $11.75 Billion
Sun Pharmaceutical Industries officially entered the biosimilar market, by announcing its $11.75 billion acquisition of Organon. Organon was spun off from Merck in 2021, and focused on both biosimilar commercialization and the sales of other branded pharmaceuticals, including women’s health products. Mumbai-based Sun Pharma is India’s largest generic pharmaceutical manufacturer.
Under the transaction, Organon will be merged with the parent company’s Sun Pharma subsidiary. The transaction should close in early 2027.
In statements made in Sun’s press release, it is unclear what value Sun places on the biosimilar part of Organon’s business. However, the move does position Sun as a global biosimilar player, with a presence in 150 countries. Will Sun leverage Organon’s position as a biosimilar commercialization partner and contract with other manufacturers and/or will Sun move into the biosimilar R&D game as well?
Biosimilars as a Natural Evolution for Generic Manufacturers
The moves by Amneal and Sun may presage moves by other generic drug makers to expand their horizons. As we’ve seen and heard at the recent meetings and at IQVIA presentations, the generic drug industry is at a crossroads—profits are being squeezed out and generic drug launches are slowing to a trickle. Scott Biggs of IQVIA stated at the Association of Accessible Medicines Access! Meeting earlier this year, “In 2018, it took seven branded drugs to equal the total revenues of the generic business; today, it only takes two.”
Generic company sustainability is certainly an issue, and the biosimilar field seems a natural expansion for these companies. This is especially true as efforts to streamline the biosimilar development process significantly lowers the costs of entry.
Although a few biosimilar manufacturers have found handsome profits in the biosimilar industry, many find only limited revenues for several products, including those with small market shares of adalimumab, pegfilgrastim, ranibizumab, infliximab, and others. However, $50 million in annual revenues for an individual biosimilar may be acceptable to a generics company with 50 other products in their portfolio. Ask generic manufacturers like Biocon, Amneal, and Dr. Reddy’s.
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.
