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 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.

(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 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.

Biosimilar Aspects of the GLOBE Final Rule

With the publication of the GLOBE model final rule, CMS outlines exemptions that seem to reduce the value of the program significantly. It also specifies biosimilar impacts of GLOBE.

As published in final rule form, the federal government’s Global Benchmark for Efficient Drug Pricing Model (GLOBE) seems a lot less significant than when it was first proposed in December 2025.

Intended as a method to apply Medicare’s Most Favored Nation (MFN) pricing to Part B biologics, the GLOBE demonstration model has numerous exemptions and exclusions that seemed to render it very limited in scope, according to a simple analysis posted by Brian Reid on LinkedIn. The final rule lists 36 eligible medications for year 1 of the demonstration. This number is quickly whittled down to 4 drugs, because the manufacturers of the other 32 products already have agreed to Medicaid MFN deals, which exempt them from GLOBE. One of those four medications, vedolizumab (Entyvio), will no longer be eligible for GLOBE discounts in January 2028, because Medicare negotiated pricing will take effect.

Five Biosimilars Affected by GLOBE in Year 1

From a biosimilar standpoint, five products—aflibercept, denosumab, golimumab, natalizumab, and tocilizumab—are listed but already have approved and marketed biosimilars (except golimumab, which is not yet marketed). They would be exempt from any MFN agreements. Besides, the biosimilar competition would likely result in lower discounts than can be obtained through MFN or Medicare Fair Price negotiations (MFP).

Endpoints News cited that the savings estimate originally cited at the introduction of the GLOBE project was $11.9 billion; based on the final rule, this figure may be 4% of that original amount or approximately $440 million. That savings amount doesn’t seem worth the effort. Was it nothing but an effort at coercion to force companies to sign Medicaid MFN agreements?

In the GLOBE final rule, CMS specifically states in its response to public comments that it is primarily concerned with lowering existing Medicare costs on these Part B products prior to biosimilar entry and not with effects on future biosimilar development. This is not surprising, as CMS has not expressed concern in the past with MFP or MFN efforts on discouraging biosimilar development on eligible reference biologics.

One other interesting aspect of the GLOBE final rule is the clarification of biosimilar exemptions. This is based on when the biosimilar product is actually marketed. CMS will rely on ASP pricing eligibility for this information plus listing in the FDA’s Purple Book and be identified as “sold or marketed as set forth in 42 CFR 427.20.” This means, “CMS would use marketing data as listed in either the ASP data reported to CMS by a manufacturer or the NDC directory to identify a start marketing date for the biosimilar biological product in the US prior to the applicable calendar quarter when the product meets one of the following criteria: (1) the NDC has units reported for the rebate quarter; (2) the end marketing date is during the rebate quarter; (3) the end marketing date is after the rebate quarter; or (4) the end marketing date is missing.”

Also, the final rule addresses unbranded (reference) biologics or authorized generics: “…authorized generics and unbranded biological products, are directly or indirectly, sponsored by the original pharmaceutical drug manufacturer, [therefore,] we believe that if an authorized generic or unbranded biological product is included in the Medicare Part B Drug Inflation Rebate Program, then, subject to the exclusions described in §513.130(c), it could be included in the GLOBE Model.”

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?

US Humira Sales Overwhelmed by Biosimilar Competition

Adalimumab biosimilar utilization account for more than 80% of the drug category, as AbbVie’s Humira revenues dry up.

Although the numbers are hard to come by, it seems apparent that adalimumab biosimilar sales have pounded the reference product Humira into submission through the second quarter of 2026. AbbVie announced Humira net revenues of only $425,000,000 for the second quarter, another massive drop of 47% versus the same quarter of last year.

The utilization numbers involving biosimilar forms of adalimumab have been complicated by the significant sales of private-label versions through the big 3 PBMs and their subsidiaries. Based on reporting by IQVIA, not all of these private-label prescriptions are reported directly; however, the Pharmaceutical Resources Group recently indicated that the total share of AbbVie’s Humira prescriptions is now below 20%. This roughly aligns with the latest earnings report from AbbVie, showing titanic reductions quarter over quarter. Prior to biosimilar competition in 2023, AbbVie netted $18.6 billion in US sales; it is on track for closer to $1.5 billion through the end of 2026.

As pointed out by Bryce Platt at Drug Channels Institute, and by us in the past, the lowest-price discounting for adalimumab biosimilars has not guaranteed increased preferential coverage for utilization. Instead, private-label contracting by the biosimilar manufacturer seems to move the needle more significantly.

As Skyrizi and Rinvoq Fill the Revenue Gap, Do Health Plans Further Restrict Their Use?

In any case, no one is feeling sorry for AbbVie these days because of the bloated numbers being posted for Skyrizi and Rinvoq sales. These are easily taking up the slack for the hole created by cratering Humira revenues. As a related question, it would be interesting to better understand whether health plans have now firmly decided to require a low-cost adalimumab step prior to covering either Skyrizi or Rinvoq for patients with the dozen or so immunology indications that they are approved to treat.

It’s not a simple question. For example, UnitedHealthcare’s medical coverage policy for Skyrizi in plaque psoriasis requires use of “documentation of moderate-to-severe disease plus failure of at least one conventional systemic therapy (methotrexate, cyclosporine, PUVA, or acitretin) OR prior treatment with any targeted immunomodulator like TNF inhibitors or other biologics.” It also varies by indication: CIGNA’s coverage policy for Skyrizi and Rinvoq in Crohn’s disease and psoriatic arthritis lists it as a preferred step 1 agent, along with adalimumab, Tremfya, Taltz, and ustekinumab biosimilars, whereas Rinvoq is nonpreferred (where patients are directed to adalimumab specifically). This is accompanied by many specific criteria allowing for exceptions to the coverage policy. Then, of course, is the difference between medical coverage and pharmacy coverage policies for these mostly self-administered products.

From a quick scan of these coverage policies, it does appear that the adalimumab and ustekinumab biosimilars have been firmly set as first-step options among biologics. The question of whether their own use require fewer prior authorization criteria (or even no prior authorization scrutiny?) has not been answered. It is extremely important to point out that, as inexpensive as adalimumab biosimilars are today, and as easy as they are to access, these are biologic agents with potentially serious side effects and complications. They are not for every patient, and therefore, prior authorization criteria should probably remain in place, even as they grow in utilization and remain inexpensive.

In Other Biosimilar News

According to an agreement between Sandoz and Shanghai Henlius, Sandoz will have global commercialization rights (outside of China) to up to 10 potential biosimilar candidates being developed by Henlius, including three announced agents: evolocumab (reference product, Repatha) for the treatment of hypercholesterolemia, belimumab (Benlysta) for the treatment of systemic lupus, and cetuximab (Erbitux) for the treatment of colorectal cancer.

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.

Why State Employee Health Plans Should Push Hard for Biosimilar Use

A focus on biosimilars will save individual state employee health plans a conservative average of over $17 million, based on net costs.

A new survey from the Pacific Research Institute found that a greater focus on biosimilar utilization will save individual state employee health plans on average over $17 million each year, based on net costs.

In 2024, the year on which savings calculations were based, adalimumab biosimilars had begun to significantly cut into Humira’s market share, and savings were already being registered in a number of biologic categories, especially the oncology-related therapies.

State employee health plan savings with biosimilars

The study used data from CMS, IQVIA estimates, and a third party’s estimate of nonretail prescription drug expenditures. Based on these three sources, state private health insurance plans spent $20 billion on biologics in 2024. The author, Wayne Winegarden, PhD, Senior Fellow at Pacific Research Institute, confirmed to BR&R that these estimates are based on net prices, not gross costs. He estimates that roughly one-quarter of those expenditures were spent on biosimilars in categories of biologics with biosimilar competition, or a total of 7% of overall biologic expenditures.

State Employee Health Plans Save Big With Biosimilars

The research assumed two different scenarios: (1) biosimilars attain 52% of the biologic volume in categories with biosimilar competition (or 15% of overall biologic expenditures) and (2) 81% within those categories, or 24% of the overall biologic spend.

The author found that across the US, savings ranges from $871 million to $1.8 billion each year. From the analysis of individual states’ public employee health plans, biosimilars will save annually in the range in the from $0.9 million in Wyoming to $88.4 million in California (conservative scenario). In the more aggressive scenario, the biosimilars savings range was $1.8 million in Wyoming and $178.9 million in California.

Dr. Winegarden concludes, “Due to the savings potential, prioritizing biosimilars in state employee health plans will enhance the fiscal soundness of the state budget while ensuring state employees have access to efficacious treatments. This is an easy win-win outcome that will benefit both taxpayers and state employees.”

In Other Biosimilar News

According to a report in the Korea Biomedical Review, Celltrion was given the FDA interchangeability designation for its rituximab biosimilar product Truxima. This is perplexing for all of the reasons I’ve stated in the past: (1) the drug is not covered under the pharmacy benefit so it is not subject to the sole automatic substitution purpose of the designation and (2) the interchangeability designation does not in any way infer that the product is better than another biosimilar, yet the report noted that “Truxima remains the only rituximab biosimilar officially recognized by the FDA as interchangeable with the reference product, which it believes will provide a competitive advantage through greater physician confidence and market differentiation.” Any suggestion that an interchangeable is better than a conventional biosimilar is false. Rituximab biosimilars were first approved in 2018. How much additional confidence do prescribers need?