Preparations Being Made for Much-Delayed Introduction of Enbrel Biosimilars

Samsung Bioepis and Teva announced a deal in which Teva will commercialize Samsung’s etanercept biosimilar Eticovo; launch date should be in 2028.

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

The Long Delay to Etanercept Biosimilar Launch Nearing the End

Even though two etanercept biosimilars were approved by the FDA in 2016 and 2019, respectively, judicial interpretations of the reference product’s patent expirations have kept the biosimilars off the US market for more than a decade relative to its EU launch. Without the ability to commercialize the biosimilar until at least 2028, other biosimilar manufacturers have avoided further development. At an annual net sales revenue of around $3 billion, Enbrel’s manufacturer (Amgen) has reaped at least $30 billion in additional sales since the first etanercept biosimilar approval.

Sandoz has not yet disclosed commercialization plans for its etanercept biosimilar Erlezi, but it has been very active on both the manufacturing phase and as a marketing partner. As there still only two etanercept biosimilars approved in the US, there may still be significant sales opportunities for these products.

As part of the new agreement, Teva will also obtain US commercialization rights to Samsung Bioepis’ infliximab biosimilar Renflexis in the third quarter of 2027. Organon and its predecessor Merck had possessed the rights to this biosimilar product since its launch in 2017.

According to the agreement, “Teva will pay Samsung Bioepis an upfront payment over the next 3 years. Samsung Bioepis may be eligible for additional launch and sales milestones payments. Teva and Samsung Bioepis will share profit from the commercialization of these products.”

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.

Pfizer Oncology Biosimilars’ Falling ASPs

The average sales prices for Pfizer’s trastuzumab and rituximab biosimilars are falling far below those of their competitors’—by as much as 93%.

In the newly released fourth-quarter report on biosimilar trends from Samsung Bioepis, one item stood out among the sea of now-familiar trend lines: A new drop in average sales prices (ASPs) for two oncology products, both from Pfizer.

Falling ASPs — Adapted from Samsung Bioepis’ Q4 2026 Biosimilar Trend Report

The notable developments represent some large changes on a percentage basis. For Pfizer’s trastuzumab biosimilar, Trazimera, the ASP has dropped from $325 for a 420-mg dose in the third quarter, to $255 for the same dose in the fourth quarter. This is nearly 75% below the ASPs for the three closest competitors (Ogiviri at $1,021, Hercessi at $1,052, and Ontruzant at $1,159). This is also 93% below the ASP of the reference product Herceptin.

However, the difference is even greater for Pfizer’s Ruxience. In the third quarter of this year, its ASP was $531 for a 500-mg dose. This has dropped precipitously, to only $289 for the same dose. The next closest competitor is Riabni, at $782. (In the Samsung report, the price was listed at only $18. This may be the result of erroneously removing the product’s 8% ASP markup [of $5.44 per 10 mg] from CMS’s listed average manufacturer’s price. Many thanks to IPD Analytics for their help in the calculation). Ruxience’s current ASP is now 92.5% below the ASP price of the reference product Rituxan.

However, the demand for these two biosimilars does not seem to follow the pricing. Consider that the ASP data are reported for the fourth quarter of 2026, and the marketshare data is from the second quarter, so there is a 6-month gap or lag. Still, both of these Pfizer products were the least expensive in their respective drug categories for the third quarter as well.

In the trastuzumab class, Trazimera has a 21% marketshare, behind Kanjinti (at 35%) and Ogviri (at 23%). Kanjinti’s ASP is the highest for a biosimilar trastuzumab, at $2,464, with Ogviri at around $1,100, about fivefold greater than Trazimera. For rituximab, Ruxience is the number 2 rituximab biosimilar, at 34% marketshare, behind Truxima (at 37%). Truxima’s ASP was $1,527, or fivefold more than Ruxience.

This sounds like another opportunity for Medicare plans to employ reference pricing to help drive buy-and-bill providers towards the lowest-cost agent.

In Other Biosimilar News

Xbrane Biopharma and STADA Arzneimittal secured FDA approval for its ranibizumab biosimilar Lucamzi (ranibizumab-blrz) on October 26. This marks the fourth ranibizumab biosimilar approval, and the first US biosimilar approval for the Swedish manufacturer Xbrane. In a press release, the company announced a planned 2027 “together with its partners.” A commercialization partner in the US has not yet been disclosed.

“FDA approval of Lucamzi is a landmark event for Xbrane, representing a key opportunity to reach many more patients and to realize a return on our development investments,” commented Martin Åmark, CEO of Xbrane.

(This post was updated October 29th to reflect STADA Arzneimittal’s co-development arrangement with Xbrane.)

Lower Costs for Biosimilar Development Will Yield Myriad Benefits: Part 2

The removal of the phase 3 trial mandate for biosimilar manufacturers opens the door for lower development costs and for new biosimilar players. At last week’s Festival of Biologics program in Basel, sessions focused on pembrolizumab biosimilar activity driven by these lower costs.

Formycon’s Pembrolizumab Case Study

On October 13, the news had just been announced that the FDA had accepted Formycon AG’s 351(k) application for FYB206, marking the first pembrolizumab biosimilar candidate to reach that milestone. That day, Andreas Seidl, PhD, Chief Scientific Officer, Formycon AG, detailed why the company avoided comparative efficacy trials on FYB206.

This case study spoke to the scientific rationale for a pharmacokinetic (PK)-focused development program. The updated guidance from the FDA, said Dr. Seidl, specified that comparative efficacy studies (CESs) should only be conducted if they will provide meaningful additional information.

In the case of the reference product Keytruda, the molecule has high affinity for the target PD-1 receptor. The biology of pembrolizumab is well characterized, and its mechanism of action is well understood. It is a humanized IgG4 monoclonal antibody, and analytical similarity can be adequately demonstrated. As a result, any CES would not provide added value. Dr. Seidl stated, “At the approved dose, saturated target engagement and a flat exposure-response relationship limit the sensitivity of the comparative efficacy endpoints. A PK-focused program is proportionate when the integrated evidence sufficiently resolves residual uncertainty.”

Formycon’s FYB206 has comparable parameters, including PK and molecular weight, to the reference product, and their glycan profiles are highly similar. This translates into comparable neonatal Fc receptor (FcRn) binding. The company negotiated with FDA that a late-stage CES study was unneeded. Their PK study comprised 96 patients with completely resected stage II/III melanoma. This study also assessed the safety and immunogenicity of FYB206, as well as an exploratory efficacy endpoint.

With Changes to the Phase 3 Trial Mandate, the Race is on for New Biosimilar Manufacturers

Bert Thomas, PhD, Senior Vice President of Business Development, Bio-Thera Solutions, emphasized that removing the late-stage CES requirement has been a priority point of discussion at the Festival of Biologics meetings for years. “Once the dam broke, pretty much everyone else followed, because the science is there.

“The hope is lower prices through lower development costs, faster development timelines, and more competition.” As a result of these efforts, he said it may be possible to start considering biosimilar competition for lower-revenue biologics. “The promised land is filling the biosimilar void,” proclaimed Dr. Thomas.

Based on the high costs of development, Bio-Thera had exited the oncology biosimilar arena. They re-entered the field with a pembrolizumab candidate (BAT3306), only because the phase 3 trial mandate was removed.

“We all go after biosimilars for the same high revenue targets. In reality, after the phase 3 clinical trial mandate was removed, there are many new players,” said Dr. Thomas. He stated there are more than 30 pembrolizumab biosimilars globally, and at least 15 dipliumumab biosimliars in various stages of development. “Most of these players don’t have an existing FDA or EMA approval—there is a learning process there. Do they know how to get a phase 3 waiver? How do they ask questions of the regulator? Do they have the capacity to support global launches? And the intellectual property challenge with originators is not getting easier or cheaper,” he pointed out.

The change to the phase 3 trial mandate has also changed the outlook of major biosimilar players: Samsung Bioepis, Celltrion, and Sandoz all announced significant pipeline expansions in the past year alone. These moves will also carry their commercialization partners (e.g., Teva, Harrow, Hikma, and Accord to name just a few) into more product areas.

Lower Costs for Biosimilar Development Will Yield Myriad Benefits: Part 1

At last week’s Festival of Biologics program in Basel, biosimilar attendees were treated to a preponderance of sessions involving streamlined biosimilar development—specifically, the removal of the phase 3 trial mandate by major regulators.

Although BR&R is keenly focused on the US biosimilar market, this year, we wanted to get a global perspective, by attending the Festival of Biologics European conference. Perhaps unsurprisingly, our colleagues on the continent are focused on the same hot topics that drive us in the US: development costs, competition, access, and government regulation.

At last week’s program in Basel, sessions featured the implications of streamlined requirements for biosimilar development—specifically, the removal of the phase 3 trial mandate by major regulators. Speakers addressed the cost savings resulting from this sea change in registration requirements, how it can spur activity within the biosimilar void, and what it means for biosimilar competition overall.

Biosimilars’ Value and Cost Savings to Shine With Lower Development Costs

Amidst the pressures on market access and pharmaceutal pricing, “Biosimilars are one of the clearest examples of how to create value for the whole healthcare system,” said Isabel Remus, Global Head of Biosimilars, Sandoz.

“The opportunity ahead is unlike anything we’ve seen before,” she stated, based on value of biologics that will lose exclusivity in the next decade.

With the cost of healthcare innovation continuing to rise, health systems in each country need to be funded in a sustainable way. “Biosimilar competition is a key lever for value,” said Ms. Remus. Across different healthcare systems, there is strong evidence on how biosimilars create value. For example, in the EU, biosimilar competition generated 75 billion euros in cumulative savings, over 9.2 billion patient-days of utilization. In comparison, the US health system saw $56 billion in savings. These savings can contribute to both broader access to valuable biologic medicines as well as funding innovation for new disease treatments.

However, not all patients benefit equally from biosimilar access. Adoption remains uneven between countries and regions, she pointed out. Some reference products attract a lot of biosimilar competition, whereas some generate very little or none. “Removing key barriers can materially reshape what is achievable in biosimilar development,” Ms. Remus said. “We’re trying to get the time of biosimilar development down to 4-6 years at a cost per program down to $60 million to $150 million. Regulatory evolution can open future opportunities and open opportunities previously thought to be closed.”

This may be one of the most important periods in the history of biosimilars, she concluded. The environment is becoming more complex. “Success will require not only flawless execution but the ability to anticipate policy changes.”

Fifty Percent Savings in Total Cost of Biosimilar Development Is Possible When Avoiding the Phase 3 Trial

According to Mourad Rezk, MD, MSc, MBA, CEO, RezMed Consulting, the impact of waiving comparative efficacy studies (CESs) could be game changing for developers. He believes that the lower cost to bring a biosimilar to market may make it possible to consider reference product targets with far lower revenues than in the past, perhaps as low as $350 million per year.

Consider that CESs went from being a default requirement to only being required in exceptional situations within 5 years, starting with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2021. Since that time, the major pharmaceutical regulatory agencies “have come to the same conclusion but are not yet fully aligned on wording of their guidances. We need more harmonization,” said Dr. Rezk.

He outlined the few instances when a CES may still be required for regulatory approval:

If the molecule is heterogeneous or poorly characterizable
If the mechanism of action is not completely understood or it may have multiple mechanisms of action
If the molecule is locally acting, and pharmacokinetic studies are not informative
If the compound carries a high risk of immunogenicity or carries severe consequences if immunogenicity occurs
If the biosimilar is the first applicant for a complex reference molecule

Some companies have chosen to continue their phase 3 studies, particularly with pembrolizumab biosimilar candidates. But with 50% savings potentially obtained through the avoidance of these CESs, some new players may decide to join the fray, Dr. Rezk believes. When you start to consider lower-revenue reference drug targets, it may be possible to “avoid the [biosimilar] void.” It may also be a boon for biosimilars in the rare disease space, he hoped.

Does the Direct-to-Employer Route for Biosimilars Make Sense?

Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option.

Waltz Health, a digital health company, has announced that it has agreed to team with Fresenius Kabi to help supply its three biosimilars in a direct-to-employer arrangement through its existing Waltz Connect platform.

First reported by Fierce Healthcare, the biosimilars that will be available direct-to-employer will be Fresenius Kabi’s Idacio (adalimumab), Tyenne (tocilizumab), and Otufli (ustekinumab). Waltz Health already has direct-to-employer arrangements with Eli Lilly and Novo Nordisk for their GLP-1 products.

By using Waltz Connect, corporate members can avoid traditional wholesaler and pharmacy benefit manager arrangements (and thus avoid rebate contracts). As the products are still delivered through specialty pharmacies, the typical provider and patient supports can still be provided.

The Direct-to-Employer Benefit for Biosimilars

This channel would appear to assure that patients directly benefit from discounts received by the corporate employer. In Fierce Healthcare, Fresenius Kabi’s President of Biopharma Sang-Jin Pak, MD, stated, “As we continue to expand our biosimilars portfolio, we remain focused on innovative partnerships that help employers and payers access high-quality treatment options.”

Employer benefit consultant F. Randy Vogenberg, PhD, told BR&R, “Making the costly drug purchase experience easier and engaging for the consumer as patient remains important. Leveraging biosimilar solutions could further the value to employers and their plan beneficiaries (patients) as other market forces change coverage affecting access to treatment options.” Dr. Vogenberg, Principal, FRV Health Strategy Advisory, Greenville, SC, said, “Addressing economic coverage gaps can be a win–win short-term solution for multiple stakeholders.”

Assuming that the employers signing onto Waltz Health have access to the same pricing for biosimilars as PBMs and others do, this seems a natural option. In surveys, employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves.

In Other Biosimilar News

Teva Pharmaceuticals received its second FDA approval for its denosumab biosimilar. After receiving its approval for Ponlimsi in March, referencing Prolia, to prevent osteoporosis, Degevma, referencing Xgeva, will be prescribed to prevent skeletal-related complications in patients with multiple myeloma or bone metastases. Teva plans to launch both products “in the coming months.” It joins a crowded field of 9 manufacturers with both denosumab indications.

Meitheal Pharmaceuticals announced September 28 that the FDA approved its high-concentration formulation of Yusimry, the company’s adalimumab biosimilar. The company will now be able to compete for prescriptions for this most-used adalimumab biosimilar formulation. “With this approval, we now have FDA approval for both low- and high-concentration formulations of Yusimry, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. In July, the company had also received FDA approval for its insulin aspart biosimilar Garzulys, which is produced by Emerge Bioscience. Meitheal has marketing responsibility for this agent.

Is the 505(b)2 Pathway Viable for Biosimilars?

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.

Infographic comparing 505(b)(2) drug approval and 351(k) biosimilar pathways

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.

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.

“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.”

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.

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.

Trump Tariffs on Generics and Biosimilars: Utter Nonsense or Just Plain Stupidity?

Trump’s desire to remove a drug tariff exemption for generics and biosimilars produced overseas is ill-conceived and truly damaging to these low-margin industries.

The Trump administration seems to think that making generics and biosimilars more expensive to the health system and consumers alike is a great idea.

On July 21, President Trump posted on social media that he intends to remove an exemption for generic drug makers from pharmaceutical tariffs and place a 100% tariff on these products in 2028. The Trump tariff would rise to 200% if manufacturers do not start producing these drugs on US soil by 2029. The Administration’s definition of generic drugs includes any nonbranded products, and biosimilars are therefore part of this category.

The Supreme Court ruled that the administration cannot legally usurp Congress’s authority to apply taxes or tariffs for arbitrary purposes. This action would not only be arbitrary but damaging to the very foundation of the biosimilar and generic industries.

The reason for the existence of generics and biosimilars is to provide lower cost pharmaceuticals to patients, payers, and the health system in general. The basis for lower costs for generics and biosimilars is competition, not decree. If a legitimate business case could be identified to support the implementation of these Trump tariffs, a portion—if not all—would be passed onto payers and consumers, thus raising the net price of generics and biosimilars. The administration seems to ignore this basic business practice.

Generic Drug Margins Already Extremely Low

We have reported that the generic manufacturing industry suffers from low margins, which have reduced production and contributed to drug shortages in the US. A substantial tariff on these medications will initiate discussions in the boardroom as to whether their falling profit margins justify the building of US-based facilities just to avoid the additional tariff costs. Some, if not many, manufacturers will answer this question negatively.

Cutting Into Biosimilar Development

On the biosimilar side, where margins are greater but revenues may still be lower than expected for some biologics, the Trump tariff will counter some of the legislative proposals intended to streamline biosimilar development that are just now moving through Congress. Furthermore, the initiative will further threaten our ability to shrink the biosimilar void, and discourage future biosimilar development.

Removing an exemption for generics or biosimilars on a more general pharmaceutical tariff is ill-conceived and short-sighted. Certainly, no Congress that is actively trying to amplify biosimilar competition and reduce development costs would agree that tariffs of this nature justify the risks.

This is a terrible idea, and it might be further evidence that someone needs to monitor the president’s social media posts before they are sent.

In Other Biosimilar News

A real-world postmarketing study of Samsung Bioepis and Harrow’s Byooviz confirmed its associated clinical outcomes were equivalent to those of the reference product Lucentis, according to Korean researchers.

Interim results of this open-label observational study were presented at the annual meeting of the American Society of Retinal Specialists, July 15–18, in Montreal. The interim data reported results on 298 patients treated from May 2022 to May 2026. One hundred eighty-two participants did not have previous VEGF inhibitor treatment, and 116 were switched from the reference product. After 24 weeks of treatment, Byooviz’s efficacy, in terms of best-corrected visual acuity and central subfield thickness, was not significantly different than Lucentis, without new safety concerns. Although the efficacy results of this comparative study were unsurprising, the study’s authors also pointed out that disease duration prior to treatment was significantly related to worse outcomes, supporting that the earlier the treatment, the better chance for visual improvement (regardless of ranibizumab product used).