Fresenius Kabi Expands Biosimilar Pipeline With Deal for Next-Generation Molecules

Joining forces with a Chinese biologics company enabled Fresenius Kabi to obtain rights up for up to 37 biosimilar candidates over the next decade.

Fresenius Kabi, a serious player in the US biosimilar arena, had been seeking ways to bolster its biosimilar pipeline, and it made quite a splash earlier this week. The company signed an agreement with the Chinese-based WuXi Biologics, vastly expanding the Fresenius Kabi biosimilar pipeline. This comes after completing its acquisition of another biosimilar manufacturer last month.

Through October 2026, Fresenius owned several biosimilar approvals: adalimumab (Idacio), denosumab (Conexxence/Bomyntra), pegfilgrastim (Stimufend), rituximab (Zimrixby), tocilizumab (Tyenne), and ustekinumab (Otulfi)). PB016, a vedolizumab biosimilar in the Fresenius Kabi biosimilar pipeline through a partnership with Polpharma) is currently in FDA review. It also has Opdivo and Keytruda biosimilar candidates in development, among others.

Adding to the Fresenius Kabi Biosimilar Pipeline

The new deal will provide “exclusive option rights for up to 37 potential first-to-market biosimilar candidates,” expanding Fresenius’ present portfolio from 29 marketed and pipeline molecules “to up to 66 in the next decade.” According to Fresenius, this will provide a “next-generation portfolio” that covers “13 therapeutic areas and multiple biologic technologies, including monoclonal and bispecific antibodies, antibody–drug conjugates, and fusion proteins.”

No monetary value was placed on the agreement, but Fresenius disclosed that it will pay WuXi Biologics on a “fee-for-service basis for each biosimilar candidate that Fresenius selects for development.”

Fresenius also announced that it had purchased the remaining shares of mAbxience in October, completing its full acquisition of the company. This move had also added to Fresenius’ biosimilar pipeline.

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.

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.”

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.

First Opdivo Biosimilar FDA Application Submitted by Amgen

Amgen became the first manufacturer to submit an application to the FDA for a nivolumab (Opdivo) biosimilar. It also was the first to be sued for patent infringement.

Last week, Amgen became the first manufacturer to disclose that they submitted an application to the FDA for a nivolumab (Opdivo) biosimilar. In doing so, Amgen also became the first manufacturer to be sued by the reference manufacturer Bristol-Myers Squibb for patent infringement.

The company disclosed the 351(k) application during a business presentation on September 10. Amgen’s product, ABP 206, is one of several publicly disclosed nivolumab biosimilar candidates. The company reported, “...for ABP 206, our biosimilar candidate to OPDIVO, our Biologics License Application with the FDA has been submitted and accepted for review. We expect an FDA action on that BLA by end of the year.”

Net 2025 US revenues for Bristol-Myers Squibb’s PD-L1 inhibitor were $5.9 billion. The intravenously administered drug was first approved in 2014 (and market exclusivity ends this year), and its main patent expiration is expected to expire in 2028. Bristol-Myers Squibb also introduced a subcutaneously administered version of Opdivo in 2024, which is approved only for specific cancers. Among other manufacturers who have publicly disclosed potential nivolumab biosimilars Sandoz, Xbrane, Henlius, and mAbxience, are in various stages of development.

Patent Infringement Suit Filed Against Amgen’s Opdivo Biosimilar

Within days of the announcement of Amgen’s FDA biosimilar application for ABP 206, Bristol-Myers Squibb initiated a lawsuit claiming infringement on at least 7 patents on their product. We estimate the earliest expected launch date for intravenously administered nivolumab biosimilars to be in 2029 based on a main patent expiration in late 2028. Based on past experience, the likelihood of a settlement between the two parties may be lower than for other prospective biosimilar manufacturers, as Amgen has been willing to go at-risk for launch in the past (specifically for its aflibercept biosimilar Pavblu, a product with a similar market size as nivolimumab).

Of further interest, Opdivo is often prescribed in combination with Yervoy (ipilimumab), which is also the focus of considerable biosimilar research (also involving Amgen). Amgen also disclosed during its business presentation that it intends to file its biosimilar application for ABP 234, its biosimilar candidate to compete with Keytruda, before the end of the year.

Biosimilar Bytes: Alvotech Biosimilar News and 6-Month Ustekinumab Switching Outcomes

Alvotech has a new vedolizumab BLA and new marketing partner, and Stelara biosimilars produced equivalent clinical outcomes to the reference product over 6 months of treatment.

Alvotech’s Second Application for Vedolizumab Biosimilar and New Marketing Partner

Alvotech announced that the FDA has accepted its 351(k) application for a prefilled syringe and autoinjector formulation of vedolizumab. This product, dubbed AVT80, follows Alvotech’s previous submission of an FDA application for AVT16, the intravenous formulation of the same integrin inhibitor. According to a company Email to BR&R, Alvotech utilized two separate compound designations for this Entyvio biosimilar, because the reference compound was approved under two separate biologic licensing applications. Teva is the marketing partner for both formulations. The second vedolizumab biosimilar application, submitted to the FDA by Fresenius Kabi and Polpharma, was for the intravenous formulation only.

In separate Alvotech news, it has signed an agreement with Lotus (and its US-subsidiary Alvogen) to market AVT34, a proposed duravalumab biosimilar, and AVT 87, a proposed emicizumab biosimilar. Duravalumab (Imfinzi) is a PD-L1 inhibitor, with multiple cancer indications. The major patents for this product may not expire until after 2035. Emicizumab (Hemlibra) is a bispecific factor IXa- and factor X-directed antibody to prevent bleeding episodes in patients with hemophilia A. First marketed in 2017 as well, this product’s main patent expires in 2032, according to sources. The agreement is not exclusive, and may result in Alvotech also marketing these products in the US. In addition, it applies to selected Asian markets.

Stelara Biosimilars Work Well in Italy, With Little Switching Back

An Italian study published online in Clinical Gastroenterology and Hepatology found that switching from Stelara to ustekinumab biosimilars resulted in equivalent success rates (92%–93%) in 337 adult patients with Crohn’s disease after 6 months of treatment. The study group was compared with 125 patients who continued to take the reference product. Only 1.2% of patients switched back to the reference product. The authors noted that longer-term data would tell a more comprehensive story for this chronic therapy.

The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics

Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors?

This week, Teva received an appellate court ruling on the IRA Medicare Fair Price (MFP) question as to whether a generic drug (or biosimilar) is to be considered a “bona fide” marketed product. This gets to the very heart of whether the reference product or originator brand is eligible for the MFP IPAY negotiations in the first place.

In Teva’s case, the DC Appellate Court ruled that the challenge to the Centers for Medicare and Medicaid Services definition of bona fide marketing is valid. In its decision, the Court stated, that CMS will consider a generic as marketed “only when the manufacturer engages in ‘bona fide marketing.’ Teva says both rules exceed CMS’s statutory authority and that the Negotiation Program deprives it of a protected property interest without due process. The Government responds that the IRA bars courts from reviewing Teva’s statutory claims. Teva’s challenge to the ‘bona fide’ marketing requirement, however, is ripe for review.”

Whereas the appellate court did not rule on the merits of Teva’s challenge to the definition, it sent the question back to the District Court with the explanation that the IRA legislation did not give CMS the authority to make this determination.

IRA MFP Controversy From the Beginning

CMS decided that ustekinumab should be eligible in the first round of IPAY negotiations, despite the large number of approved biosimilars scheduled to launch prior to the implementation of its MFP-negotiated price (January 1 2026). In November 2025, CMS decided to delist ustekinumab, in the face of active biosimilar competition, though the MFP pricing ($4,695 per 30-day supply) will apply through January 1, 2027. The current WAC cost for Stelara is down to less than $500 per month. In other words, CMS is overpaying (by a lot) this year for ustekinumab.

In the case of etanercept, it was also included in the first round of Medicare price negotiations, despite two US FDA approved biosimilar products but no expectation for launches before 2028, owing to patent extensions of dubious justification. For Enbrel, the implementation of MFP discounts makes a lot of sense, despite the likely lost future revenues by the biosimilar manufacturers.

This points to the unpredictability and challenges of evaluating potential patent settlements and launch agreements with reference manufacturers. We are already seeing the potential for this to affect Keytruda, Opdivo, and other big-ticket biologics with significant upcoming biosimilar competition.

What Is Bona Fide Marketing?

Another interesting point related to the bona fide marketing requirement is that even if a biosimilar product is approved and marketed, there is no guarantee that the manufacturer will enter into large marketing programs as are commonly seen for reference or branded products. Typically, especially on the generic side, marketing budgets are relatively low end; the manufacturers may rely on automatic substitution heavily to gain prescription volume. This consideration seems to be outside of CMS’s thought process. Personally, I’ve seen only limited traditional marketing efforts on the part of biosimilar manufacturers several specific products.

This brings us back to the original question of whether CMS has the best standard for gauging the expected launch date of a generic or biosimilar at the time it produces its list of IPAY targets for the current year. We’ve seen no evidence that there is a consistent bar or protocol through which these decisions are made. Yet, these decisions may be crucial for prospective biosimilar manufacturers and for CMS itself—biosimilars with adequate competition will always produce greater discounts and lower prices than IPAY negotiations. Notwithstanding the ability of CMS to delist in the future a product that has been exposed to biosimilar competition, if it doesn’t change its view towards eligibility of reference products, CMS will continue to waste time negotiating pricing on products that will be delisted within a year of implementation. More importantly, it would lose the opportunity to save billions of dollars from biosimilar competition for the year before delisting. And isn’t saving money what this exercise is all about?