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

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.

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.

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.

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.

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.

The Effect of MFP on Enbrel Sales, and Biosimilar Implications

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.

What Have I Got Against the Biosimilar Interchangeability Designation? Much.

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.

biosimilar interchangeability designation

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.

CVS Caremark Drops Stelara Coverage in Favor of Biosimilars

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 biosimilars. This change applies to “its most common commercial template formularies.”

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.

Will We Remember Marty Makary in 2030?

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.

FDA Commissioner Marty Makary — 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.

Biosimilar Company Acquisitions: Amneal and Sun in Separate Deals Signal More Generic Drug Maker Participation

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.

More on the Dynamics of the Biosimilar Marketplace

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) declines. Even when biosimilar competition was less than robust, prices declined steadily for some drug categories, shockingly fast for others. But the savings keep accumulating.

The Pegfilgrastim ASP Roller Coaster

The pegfilgrastim category has been fascinating since its first biosimilar was launched in late 2018. The ASP declines, plateaus, rises, and falls once again have been chronicled in this column in the past. Perhaps the main take away of the biosimilar ASP chart featured in the latest Samsung Bioepis Market Trend Report is that the graphic jumble of ASP movements have finally coalesced into a narrower range, between $1,813 at the top end for Stimufend and $839 at the bottom end for Fulphila; the latter is also the market leader with 41% share (as of Q4 2025).

The wild ASP rollercoaster of chart lines has taken three years and some stops and starts by manufacturers like Sandoz before reaching this station. Market share in this category is dominated by biosimilars, with Neulasta accounting for only 13% of volume; however, Onpro is not included in IQVIA’s data, so it is far from the whole story.

Biosimilars Leading the Autoimmune Field

On the autoimmune side, biosimilars have just reached a majority share of the infliximab market, with 51%, but the reference product (branded and unbranded Remicade) still has the greatest volume (49% vs. 30% for Inflectra). Here also, the ASPs of the various products have settled into a narrow range ($237-$293).

Based on the IQVIA data, the latest Samsung Bioepis report concedes that Humira’s prescription volume has been eclipsed by the mass of adalimumab biosimilars currently on the market. The authors peg Humira’s market share at 40%, and this is probably generous, because IQVIA does not track Cordavis private-label volume. The individual biosimilar shares are closely grouped, with Hyrimoz at 13% down to Amjevita at 4% (Nuvaila’s private-label version adds another 5%), and at least four others combining for 7% in total.

The tocilizumab market, which is about 2 years old, is showing slow gains for its three biosimilars, which comprise 18% of total prescription volume. It is led by Tyenne (16%), which also has the lowest published ASP, at $1,607, a 23% discount to the reference product’s ASP.

For ustekinumab, Stelara’s market share had already been knocked down to approximately 70%, as of Q4 2025, a far faster trajectory than that seen with adalimumab. Yesintek, at 11%, holds a narrow lead over Wezlana (7%). As we have seen at their introductions, the WAC pricing discounts have been extremely steep, led by Starjemza (–98%, or $500 total). But this is the first quarter for published biosimilar ASPs in the category, which come into play because ustekinumab requires an infusible loading dose for some indications, which is given by a health care provider under Medicare Part B. The loading dose ASPs have a wide initial range, from $286 for Steqeyma, to $1,643 for Pyzchiva. The average ASP of the biosimilars is $753, compared with $1,426 for Stelara.

A Failed Biosimilar Ophthalmology Category, or not Really?

Overall, the report details a generally, very positive biosimilar story. The one drug category where this is not the case, is ranibizumab. With the pause in commercialization of Cimerli, the low uptake of Byooviz, and the dominance of aflibercept and bevacizumab in the injectable retinal care product, marketshare of the reference product Lucentis has returned to 98%. Despite the lack of biosimilar success, the ASPs for the category hover between $320 and $398, a 72% drop cited by the report’s authors. Unfortunately, IQVIA data does not yet include the effect of the launch of the first biosimilar on the aflibercept market. We’re betting on another big success story here.

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