Rose McNulty

Government price negotiations for certain products under the Inflation Reduction Act (IRA) that aimed to rein in high drug costs may have had unintended consequences for biosimilar development, according to a new report from Matrix Global Advisors (MGA).

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies. | Image credit: japhoto - stock.adobe.com

The report comes after a separate IQVIA Institute for Human Data Science report claimed that the globe could face what the report called a “biosimilar void.”

 Essentially, 90% of the biologics scheduled to lose exclusivity in the next decade, valued at $234 billion, do not currently have biosimilars in development, showcasing a large, missed opportunity for developers.

Although the negotiated prices don’t go into effect until 2026, the first 10 products chosen for the program have been announced.

 Only products that were not at risk of having biosimilars enter the market in the next few years were supposed to be eligible for Medicare price negotiation. However, the initial list includes Stelara (ustekinumab) and Enbrel (etanercept). Several biosimilars for Stelara are currently on the market, and 2 biosimilars for Enbrel (etanercept) have been approved by the FDA, with potential launches scheduled for 2029.

“Almost all the Medicare negotiated drugs have a generic or biosimilar equivalent in the pipeline, which in turn have a significantly lower cost,” said John Murphy III, president and CEO of the Association for Accessible Medicines, in a statement on the report.

 “The Medicare drug price negotiation program artificially extends the lifecycle of the brand version, resulting in higher costs for seniors.

The MGA analysis quantified the real-world implications not only on the cost of medicines but also on the long-term negative impact on future development of generics and biosimilars, which will result in fewer competitors and more delayed competition. The better option is the proven success of reducing drug prices through generic and biosimilar competition.”

The analysis revealed that the threat of price negotiations might deter manufacturers from launching biosimilars, especially for high-sales biologics.

 A 2024 Samsung Bioepis report indicated that after entering the market, biosimilars typically achieved a 53% market share with an average 53% decline in sales price relative to the reference biologic over 5 years.

 However, given the risks and costs involved, the MGA report estimated that for each biologic with $3.5 billion in annual sales, potentially $1.9 billion in annual savings could be lost if biosimilar entry was delayed due to government negotiations.

“In the current environment, the threat of government intervention appears to be chilling the incentives for biosimilar manufacturers to enter and compete effectively in the market,” noted the report. Unlike generics, biosimilars require steep investment, and future revenues often remain uncertain. That long timeline and financial risk, combined with government pricing uncertainty, appeared to be making some manufacturers think twice before investing.

Long-term Implications for Access and Cost

The report highlighted that these delays could impact patient access to affordable biologic therapies. Biosimilars serve as a crucial mechanism to lower treatment costs for complex conditions such as rheumatoid arthritis and certain cancers. Yet, the hesitancy among manufacturers resulting from the policy environment could blunt this potential.

According to Samsung Bioepis’ report, biosimilars continued to reduce prices by 24% to 76%, depending on therapeutic areas, but the “chilling effect” posed a threat to widespread continued price declines and broader market penetration in the future.

 “The reluctance of firms to develop biosimilars due to the risk of government price negotiations will hinder the full realization of biosimilar cost savings,” the present report stressed.

Recommendations to Address the Biosimilar Gap

To mitigate the detrimental effects of the so-called “biosimilar void,” the report offered several policy recommendations. Foremost among these was re-evaluating the use of price negotiations as a tool for controlling drug costs, emphasizing the importance of fostering competitive markets instead of suppressing biosimilar market entry.

Experts suggested that policy efforts should focus on reducing anticompetitive behaviors, including patent thickets that delay biosimilar approvals. The authors highlighted that patent thickets can impede biosimilar entry, and addressing these barriers could unlock significant savings and increase biosimilar availability.

Additionally, the report called for improved market transparency and targeted incentives for biosimilar manufacturers. “Creating a more predictable and supportive environment for biosimilar development could significantly narrow the current void," the authors wrote.

While policies aimed at reducing drug costs are vital, the report cautioned that aggressive government price negotiations might inadvertently stifle biosimilar development, ultimately undermining efforts to make biologic therapies more affordable. Moving forward, policymakers were encouraged to balance cost containment measures with strategies designed to promote biosimilar competition, ensuring equitable access to these complex therapies for patients and health systems alike.

1. Brill A, Robinson C. Long-term effects of Medicare price negotiations on drug competition. Matrix Global Advisors. July 14, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/wp-content/uploads/2025/07/Matrix_Global_Advisors_Long-Term_Effects_of_Medicare_Drug_Price_Negotiations.pdf

2. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars

. February 5, 2025. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

3. Jeremias S. Stelara and Enbrel chosen for IRA price negotiation. The Center for Biosimilars. August 29, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/stelara-and-enbrel-chosen-for-ira-price-negotiation

4. Jeremias S. More ustekinumab biosimilars join US market share fight. The Center for Biosimilars. March 13, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/more-ustekinumab-biosimilars-join-us-market-share-fight

5. Biosimilar approvals. The Center for Biosimilars. Updated July 1, 2025. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/biosimilar-approvals

6. Medicare drug price negotiation has chilling effect on generic and biosimilar medicines development and availability. News release. Association for Accessible Medicines. July 15, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/resources/press-releases/medicare-drug-price-negotiation-has-chilling-effect-on-generic-and-biosimilar-medicines-development-and-availability

7. Santoro C. Samsung Bioepis reports 2024 biosimilar market growth trends. 

. October 15, 2024. Accessed July 15, 2025. 

https://www.ajmc.com/view/samsung-bioepis-reports-2024-biosimilar-market-growth-trends

Articles

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap

Despite the growing presence of biosimilar prescription drugs in the US health care market, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).

 This widespread lack of understanding could hinder the full potential of biosimilars, which are poised to expand access to life-saving medications and potentially lower health care costs across the nation. The findings underscored an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options.

The authors said their findings underscore an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options. | Image credit: Alena - stock.adobe.com

The abbreviated approval pathway for biosimilars is rigorous, allowing for more affordable treatment options and increased patient access to crucial medications for conditions like chronic skin diseases, arthritis, and cancer. However, prior research had consistently shown a lack of familiarity and understanding of biosimilars among both patients and prescribers. Misconceptions around their efficacy, safety, and interchangeability had created hesitancy in their adoption.

With the FDA having issued draft guidance in 2020 on promotional labeling and advertising for biosimilars, particularly concerning disclosure statements, the present study aimed to experimentally test how different forms of disclosure impacted understanding and perceptions.

 The goal was to identify effective communication strategies that could inform and educate both groups in a neutral manner, dispelling misconceptions without unduly influencing perceptions.

The study employed an experimental design involving 379 consumers and 368 HCPs (primary care providers with prescribing authority) recruited via an online panel. Participants were randomized into one of seven biosimilar disclosure conditions or a control group.

Each condition presented a mock advertisement for "Kesterin," a fictitious biosimilar for rheumatoid arthritis. Disclosures varied by: identifying the product as a biosimilar; the comprehensiveness of the definition provided (ranging from basic to expanded details on safety, efficacy, source, dosage, and administration); and whether a specific reference product ("Mytrozen") was named. Consumer disclosures used lay language, while HCP disclosures used medical terminology. Researchers assessed the impact of these disclosures on participants' comprehension, perceptions of benefit and risk, attitudes, intentions (to use or prescribe), and preferences.

The study's results highlighted significant knowledge gaps. Overall, comprehension of biosimilar information was suboptimal, even when participants were provided with a definition. Only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs accurately understood core characteristics, such as comparable safety and efficacy.

Specifically, comprehension was lowest for the statement, "Kesterin has the same safety and efficacy as the original biologic," for both groups. Perceptions of benefit, comparative efficacy, and safety remained largely neutral across all groups, including the control, suggesting that existing perceptions were deeply ingrained and not easily shifted by brief disclosures.

Crucially, the content of the biosimilar definition generally did not significantly influence outcomes for consumers. However, for HCPs, expanded definitions led to more positive attitudes toward the biosimilar drug and stronger intentions to prescribe. For instance, HCPs exposed to the most comprehensive definition reported more positive attitudes (mean, 4.23) compared to those who only saw the "Kesterin is a biosimilar" statement (mean, 3.83; 

 = .014) or the control group (mean, 3.80; 

 = .009). Similarly, their intentions to prescribe were significantly higher with expanded definitions (mean = 3.76) compared to the control (mean, 3.21; 

 = .009) or the biosimilar-only condition (mean, 3.00; 

Both consumers and HCPs expressed a preference for these more detailed definitions. HCPs also specifically preferred seeing the named reference product, although this did not directly impact other study outcomes, possibly due to the fictitious nature of the named reference product. Notably, HCPs largely agreed that biosimilars could be used "interchangeably" with their reference product, which signaled a potential misunderstanding of the specific regulatory designation of "interchangeability."

These findings had significant implications for the biosimilar industry and the US health care system. The persistent knowledge gaps and neutral perceptions among both consumers and HCPs indicated that the full potential of biosimilars, including their cost-saving benefits and increased access to treatment, might not be fully realized.

"Our findings clearly signaled that there were knowledge gaps and uncertainty regarding biosimilar products among consumers and HCPs," the study authors concluded. "Further education was warranted around these products, and communications for both groups required careful testing to ensure that the information was understood and did not result in a negative perception of the product."

Researchers suggested that future educational efforts should focus on providing comprehensive and easily digestible information, particularly for HCPs, given their stated preference for expanded definitions and their increased prescribing intentions when presented with more detail. For the biosimilar industry, this means refining direct-to-consumer and professional-facing promotional materials to incorporate clearer, more informative disclosures that addressed core misconceptions about biosimilar equivalence, safety, and efficacy.

For the broader health care system, effective education was mentioned by the authors as paramount to fostering trust and increasing the adoption of these important therapeutic options, which will ultimately contribute to better patient outcomes and more sustainable health care spending.

1. Johnson M, Thompson JE, Tilley AA, O’Donoghue AC, Aikin KJ. Perceptions and preferences for defining biosimilar products in prescription drug promotion. 

2. FDA. Promotional labeling and advertising considerations for prescription biological reference and biosimilar products questions and answers: Guidance for industry. 2020. Accessed July 1, 2025. 

https://www.fda.gov/media/134862/download

Significant knowledge gaps about biosimilars persist among consumers and healthcare professionals, hindering their adoption and potential benefits in health care.

Consumers and Providers Face Biosimilar Knowledge Hurdles

Celltrion announced the FDA had approved a new formulation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). The approval, for a 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection, significantly broadened dosing flexibility for pediatric patients aged 6 to 17 years who weigh less than 60 kg and live with plaque psoriasis (PsO) or psoriatic arthritis (PsA). 

"Managing inflammatory diseases in pediatric patients can be particularly complex due to varying body weights and specific developmental needs," stated Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA. | Image credit: WESTOCK - stock.adobe.com

The company stated that the strategic expansion ensures that Steqeyma now aligns with all existing dosage forms and strengths of its reference product, providing enhanced options for health care providers and individuals managing these chronic inflammatory conditions.

The FDA's decision marked a pivotal moment for pediatric dermatology and rheumatology, offering a precise dosing solution for a vulnerable patient population. Prior to this latest approval, in December 2024, the FDA had already granted approval for Steqeyma in 45 mg/0.5 mL and 90 mg/mL solutions in single-dose prefilled syringes for subcutaneous injection and a 130 mg/26 mL solution in a single-dose vial for intravenous infusion.

These initial approvals covered adult and pediatric patients aged 6 years and older with PsO and PsA, as well as adult patients with Crohn disease and ulcerative colitis. The addition of the new 45 mg/0.5 mL single-dose vial specifically addresses the nuanced requirements for precise weight-based dosing in smaller pediatric patients.

"Managing inflammatory diseases in pediatric patients can be particularly complex due to varying body weights and specific developmental needs," stated Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA.

 "This new dosage form and strength of Steqeyma allows us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." This sentiment underscored the commitment to patient-centered care, a priority for managed care organizations focused on optimizing health outcomes and treatment adherence.

Thomas Nusbickel, chief commercial officer at Celltrion USA, emphasized the broader impact of the approval. "We are proud to offer a new presentation of Steqeyma that aligns with the indications of the reference product. This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions."

The FDA’s approval of Steqeyma was built upon a comprehensive body of evidence, including the results from a phase 3 study conducted in adults with moderate to severe PsO. This study demonstrated that Steqeyma and the reference product exhibited high similarity, confirming no clinically meaningful differences in terms of safety and efficacy among adult individuals.

A key development for formulary decision-makers was the FDA’s decision to grant Steqeyma full interchangeability with Stelara across all its indications.

 Interchangeability status allows for direct pharmacy-level substitution, further simplifying access and potentially reducing health care costs.

The expanded approval of Steqeyma for pediatric patients represents a significant advancement in the treatment landscape for individuals living with PsO and PsA. By providing a full complement of dosage forms and strengths, Celltrion aims to enhance treatment continuity and improve access to a crucial therapeutic option, aligning with the core objectives of managed care to deliver high-quality, cost-effective care.

1. Celltrion announces U.S. FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients. Press release. Celltrion; June 15, 2025. Accessed June 17, 2025. 

https://www.prnewswire.com/news-releases/celltrion-announces-us-fda-approval-of-additional-presentation-of-steqeyma-ustekinumab-stba-expanding-dosing-options-for-pediatric-patients-302481004.html

2. Jeremias S. FDA approves Steqeyma: the seventh Stelara biosimilar. The Center for Biosimilars

. December 18, 2024. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar

3. Papp KA, Lebwohl MG, Thaçi D, et al. Efficacy and safety of candidate biosimilar CT-P43 versus originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomized, active-controlled, double-blind, phase III study. 

. 2024;38:121-131. doi: 10.1007/s40259-023-00630-5

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

FDA Approves Steqeyma for Children With Plaque Psoriasis, Psoriatic Arthritis

Alvotech and Dr. Reddy's to Partner on Pembrolizumab

Alvotech and Dr. Reddy’s Laboratories have announced a strategic partnership to co-develop, manufacture, and commercialize a biosimilar candidate referencing Keytruda (pembrolizumab), one of the world’s top-selling cancer immunotherapies.

 Keytruda, which is expected to lose market exclusivity in 2028, generated $29.5 billion in global sales in 2024 and is used to treat multiple cancer types, including melanoma, non-small cell lung cancer, and classical Hodgkin lymphoma. Making a biosimilar version creates a significant opportunity to improve patient access to life-saving treatments.

Under the agreement, both companies will jointly manage development and manufacturing responsibilities and share associated costs. Subject to certain exceptions, each partner will retain rights to commercialize the biosimilar globally.

The collaboration leverages Alvotech’s biosimilar research and development and manufacturing expertise alongside Dr. Reddy’s global commercialization strength and oncology focus. Executives from both companies emphasized their shared goal of delivering high-quality, affordable cancer therapies and expanding patient access to critical biologics across international markets.

German Court Bans Humira Biosimilar Over Patent Dispute

Samsung Bioepis and its European commercialization partner Biogen have been dealt a major legal blow in Germany, according to 

 The Düsseldorf Higher Regional Court ruled that their adalimumab biosimilar, Imraldi, infringes on a formulation patent held by Fresenius Kabi, which covers liquid versions of adalimumab—the active ingredient in AbbVie’s blockbuster anti-inflammatory drug. The decision reversed a 2022 lower court ruling that had favored Samsung Bioepis and Biogen.

The ruling has immediate consequences: it bans the sale of Imraldi in Germany, orders Biogen to recall and destroy existing inventory, and imposes financial penalties along with a disclosure of sales data. This raises the stakes for Samsung Bioepis, as Europe is a key market for biosimilars, and Imraldi had captured 62% of Germany’s adalimumab biosimilar market just 1 month after its 2018 launch.

The legal victory for Fresenius Kabi, which markets its own adalimumab biosimilar, Idacio, reflects intensifying competition in Europe’s adalimumab space. Although Samsung Bioepis and Biogen previously challenged the validity of the formulation patent at the European Patent Office, that effort failed, and the patent remains in force across the European Union—potentially opening the door to similar enforcement in other countries. The companies are already defending against related claims in France.

The court did not automatically grant Biogen leave to appeal to Germany’s Federal Court of Justice, though an appeal may still be requested. In the meantime, the injunction and penalties stand, putting pressure on the companies to either reformulate or reach a settlement if they want to avoid broader sales disruptions in Europe.

Samsung Bioepis has entered into a strategic agreement with NIPRO Corporation to license, develop, and commercialize multiple biosimilar candidates in the Japanese market.

 Under the terms of the deal, Samsung Bioepis will be responsible for development, manufacturing, and supply, while NIPRO will lead commercialization efforts within Japan.

Among the biosimilars included in the agreement is SB17, Samsung Bioepis’ biosimilar candidate referencing ustekinumab—a monoclonal antibody used to treat autoimmune conditions such as plaque psoriasis, psoriatic arthritis, and Crohn disease. The introduction of an ustekinumab biosimilar in Japan could provide a more affordable alternative to the originator product (Stelara), helping to lower treatment costs and expand access for patients managing chronic immune-mediated diseases.

In its statement on the new partnership, Samsung Bioepis noted that the partnership reflects growing momentum in Japan’s biosimilar market, where the government is encouraging adoption to reduce healthcare spending amid a rapidly aging population.

1. Alvotech and Dr. Reddy’s enter into collaboration to co-develop biosimilar candidate to Keytruda (pembrolizumab). Press release; Alvotech. June 5, 2025. Accessed June 17, 2025. 

https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-dr-reddys-enter-collaboration-co-develop-biosimilar

2. Samsung Bioepis, Biogen lose Humira biosimilar patent fight in Germany. Korea Biomedical Review. June 16, 2025. Accessed June 17, 2025. 

https://www.koreabiomed.com/news/articleView.html?idxno=27912

3. Samsung Bioepis enters into a strategic partnership with NIPRO for commercialization of multiple biosimilars in Japan. Press release; Samsung Bieopis;

https://www.businesswire.com/news/home/20250608582351/en/Samsung-Bioepis-Enters-into-a-Strategic-Partnership-with-NIPRO-for-Commercialization-of-Multiple-Biosimilars-in-Japan

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan. 

Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. | Image Credit: SNAB - stock.adobe.com

(Otulfi; Fresenius Kabi) had no clinically relevant effect on efficacy, safety, or immunogenicity and demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate to severe plaque psoriasis, supporting its therapeutic equivalence and potential for broader application in other indications, according to a study published in 

Even though biological therapies showed improvements in psoriasis management and other inflammatory conditions, high costs continue to limit access. Over the past decade, adalimumab, infliximab, and etanercept biosimilars have been adopted which have helped increase the number of patients who benefit from treatment.

Previous researchers found that patients with psoriasis who received either adalimumab, etanercept, or ustekinumab underwent dose escalations more frequently with ustekinumab compared with the other 2 treatments.

 They also discontinued treatment after dose escalation occurred more often with adalimumab and etanercept than with ustekinumab.

Currently, US regulatory bodies require evidence that the molecule is like the reference product in terms of structure, function, pharmacokinetics, clinical efficacy, and safety for biosimilar approval.

 Researchers have proposed dropping these blanket requirements, deeming them redundant, and modeling regulatory agencies after the United Kingdom and European Union.

Researchers conducted a multicenter randomized, double blind, parallel group phase 3 study across 27 sites in Estonia, Georgia, Poland, and Ukraine.

 About 40% of the patient population was women with an average age of 42 years, with a 24.4 mean Psoriasis Area and Severity Index (PASI) score. Of the patients, 19.4% reported prior systemic biological treatment for psoriasis, and only 9.2% of these reported an inadequate response or intolerance.

Researchers randomized a total of 392 patients to either FYB202 (n = 197) or reference ustekinumab (n = 195). Some patients did not respond (FYB202, 4; reference ustekinumab, 5), and a few patients in the reference ustekinumab group did not undergo rerandomization due to adverse events (AEs) leading to study discontinuation (n = 2) or nonattendance at week 28 (n = 1).

In the FYB202 group, 189 patients continued treatment to week 52, and researchers rerandomized 186 in the reference group (FYB202, 89; reference ustekinumab, 97). Following rerandomization, 372 patients completed the study until week 52. There were 187 patients who remained on FYB202, 97 patients who remained on reference ustekinumab, and 88 patients who switched from reference ustekinumab to FYB202.

Patients treated with FYB202 showed an estimated mean percent improvement in PASI score of 79.5% (95% CI, 74.6%-84.4%) for the primary end point from baseline to week 12, while patients treated with reference ustekinumab achieved 76.2% (95% CI, 71.5%-81%). All secondary efficacy end points were also similar between treatment groups.

Percentages of patients who reached PASI 75 (FYB202, 97.9%; reference ustekinumab, 96.4%) and PASI 90 (FYB202, 81.7%; reference ustekinumab, 78.2%) at week 28 were similar. Switching from reference ustekinumab to FYB202 had no impact on therapeutic efficacy. A total of 97.7% patients in the switch group maintained their PASI 75 response at week 52.

No differences emerged between the groups that maintained their initial treatment for the entire 52 weeks. A PASI 75 response at week 52 was maintained by 96.2% of patients in the FYB202 group and 94.6% of patients in the reference ustekinumab group.

Both treatments patients tolerated well, and researchers found the safety profiles comparable between groups. Patients reported at least 1 AE during the first 28 weeks in 39.6% of the FYB202 group and 41% of the reference group. Before rerandomization, patients most frequently reported injection site pain (FYB202, 11.2%; reference ustekinumab 7.7%), nasopharyngitis (FYB202, 4.6%; reference ustekinumab, 2.6%), and COVID-19 (FYB202, 3.6%; reference ustekinumab, 2.6%).

AEs caused 1% of patients treated with FYB202 and 1.5% of patients treated with reference ustekinumab to withdraw from the study. After rerandomization, 3 patients in the FYB202 group, 1 patient in the reference ustekinumab group, and 1 patient in the reference ustekinumab to FYB202 switch group reported serious AEs. Only 1 patient in the reference ustekinumab to FYB202 switch group discontinued because of an AE (congenital anomaly).

At baseline, 5.1% of patients in the FYB202 group and none in the reference ustekinumab group had confirmed positive adenosine deaminase (ADA) tests. ADA prevalence from week 4 to week 52 was lower for FYB202 compared with reference ustekinumab. Researchers observed the maximum proportion of patients with ADAs at week 28 in both groups.

After rerandomization, ADA and neutralizing antibody positivity declined in all 3 groups. No patients who were ADA negative at week 28 became ADA positive following the switch from reference ustekinumab to FYB202, indicating that the switch from reference ustekinumab to FYB202 did not impact immunogenicity. Mean percent improvement in PASI score from baseline to week 12 was slightly lower in ADA positive patients compared with ADA negative patients, and both treatment groups showed a similar reduction.

Researchers observed higher geometric mean C

 levels for patients treated with FYB202 compared with patients treated with reference ustekinumab, especially at early time points, which may be due to the differences in ADA incidences at the early time points as well some differences in the protein content. The serum C

 levels of ustekinumab showed a high interpatient variability particularly at weeks 4 and 12. Researchers observed smaller interpatient variability during steady state at weeks 16, 28, 40, and 52. They also observed similar and stable C

 levels from week 16 to week 52 in all 3 rerandomized groups from week 28 to week 52.

The study was not powered for statistical comparisons of equivalence after switching from reference ustekinumab to FYB202. Researchers included only a single switch, but clinical practice may involve multiple treatment switches. Additionally, regulatory authorities required the trial to detect differences between treatments for biosimilar approval, not to prove 

 efficacy. Researchers selected a narrower patient population than clinical practice might expect to ensure comparison sensitivity. Finally, the study lacked racial diversity as all patients were White, but extrapolation allows inferring similar treatment effects for other populations.

“Using a totality of evidence approach, proof of therapeutic equivalence in this sensitive psoriasis population allows for extrapolation to other indications, with similar clinical performance of FYB202 and reference ustekinumab assumed across all approved indications,” study authors concluded.

1. Papp K, Balser S, Nopora K, et al. A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the biosimilar ustekinumab FYB202 with reference ustekinumab in patients with moderate-to-severe plaque psoriasis. 

. 2025;42:2135-2149. doi:10.1007/s12325-025-03138-2

2. Santoro C. Differences in psoriasis treatment: ustekinumab dose escalation vs adalimumab, etanercept discontinuation. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/differences-in-psoriasis-treatment-ustekinumab-dose-escalation-vs-adalimumab-etanercept-discontinuation

3. Niazi SK. BioRationality: a new bill to transform the future of biosimilars. The Center for Biosimilars. May 5, 2025. Accessed June 9, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-a-new-bill-to-transform-the-future-of-biosimilars

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

Biosimilar FYB202 Shows Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

A health policy in British Columbia that required biosimilar prescriptions showed no increase in hospital visits or complications, according to real-world evidence that etanercept biosimilars for inflammatory arthritis are as effective as their originator biologics without increasing hospital utilization.

 was conducted to address the gap between clinical trial data and real-world outcomes for biosimilars, particularly among patients newly initiating treatment for inflammatory arthritis. While randomized controlled trials have established the efficacy and safety of etanercept biosimilars under ideal conditions, there remains limited evidence on how these therapies perform in routine clinical practice.

British Columbia was the first Canadian province to adopt a biosimilar switching policy. | Image credit: 93600361 - stock.adobe.com

In 2017, British Columbia introduced a policy requiring that new prescriptions for certain biologic drugs be filled with biosimilars to qualify for coverage under the public drug plan.

 The program was rolled out in several phases and has since been replicated to some extent in nearly every other Canadian province due to the success seen in BC.

 This mandate, which has already accumulated $732 million in savings in the first 5 years for the province,

 created a “natural experiment” for the researchers, who used it to evaluate health care utilization as an indicator of biosimilar safety and effectiveness in real-world settings.

“Lack of confidence in biosimilars' effectiveness, safety and interchangeability has been identified as one of the top barriers impairing the adoption of biosimilar therapies…Our findings on no unintended consequences of policy change at the health system level inform decisions in biosimilar policy development and implementation in other jurisdictions,” wrote the researchers.

The authors of the retrospective cohort study assessed the impact of British Columbia’s policy by applying a regression discontinuity design to real-world administrative health data from 2014 to 2023. Researchers identified adult patients diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who were newly prescribed etanercept. Patients were grouped based on whether they started treatment just before or just after the policy took effect, allowing for a natural comparison.

Outcomes such as hospitalizations, emergency department visits, and physician encounters were tracked for three years. Both intention-to-treat and instrumental variable analyses were conducted to evaluate health care utilization, accounting for both policy exposure and actual biosimilar uptake.

Researchers analyzed outcomes among 1626 incident users in the pre-policy period (2014-2017) and 1378 in the post-policy period (2017-2020). Demographics were similar across groups (mean age at diagnosis, 52.5 years; 63.7% female). Biosimilar initiation rose from just 0.06% pre-policy to 78.3% post-policy. Despite this sharp uptake, no significant changes in healthcare utilization were observed.

For all-cause hospitalizations (ACH), intention-to-treat (ITT) analysis yielded unadjusted and adjusted rate ratios at the policy cut-off of 0.97 (95% CI, 0.55-1.69) and 0.84 (95% CI, 0.49-1.44), respectively. Complier average causal effect (CACE) analysis showed similarly neutral effects with ratios of 0.97 (95% CI, 0.53-1.75) and 1.01 (95% CI, 0.53-1.92). Infection-related hospitalizations (IRH) were rare, and both ITT and CACE analyses showed wide confidence intervals with no statistically significant impact: the adjusted CACE ratio was 0.89 (95% CI, 0.03-23.35).

No meaningful differences were observed for emergency room visits (ERV) or hospital length of stay (LOS). For example, adjusted ITT rate ratios for LOS and ERV were 0.94 (95% CI, 0.41-2.15) and 0.91 (95% CI, 0.44-1.88), respectively. Sensitivity analyses using alternative statistical methods and bandwidths confirmed the robustness of findings. Analysis of adalimumab initiators, which were unaffected by biosimilar policy, showed no concurrent changes in health care use, supporting the specificity of the results.

“The equivalent real-world effectiveness and safety of etanercept biosimilars shown in this study will increase healthcare providers' and patients' confidence in prescribing and taking this important medication,” the authors expressed.

1. Zhou VY, Lacaille D, Zheng Y, et al. The impact of biosimilar use on healthcare utilization among new users of etanercept for inflammatory arthritis: a population-based regression discontinuity analysis.

. Published online April 11, 2025. doi:10.1016/j.lana.2025.101058

2. Davio K. British Columbia becomes the first Canadian province to mandate a switch to biosimilars. The Center for Biosimilars

. May 28, 2019. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/british-columbia-becomes-the-first-canadian-province-to-mandate-a-switch-to-biosimilars

3. Hagen T. British Columbia moves into third phase of mandatory switching. The Center for Biosimilars. August 25, 2020. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/british-columbia-moves-into-third-phase-of-mandatory-switching

4. Jeremias S. Manitoba adopts biosimilar switching policy. The Center for Biosimilars. August 7, 2024. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/manitoba-adopts-biosimilar-switching-policy

5. Jeremias S. British Columbia’s biosimilar switching program saves $732 million in 5 years. The Center for Biosimilars. June 18, 2024. May 27, 2025. 

https://www.centerforbiosimilars.com/view/british-columbia-s-biosimilar-switching-program-saves-732-million-in-5-years

Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.

British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits

The FDA today approved Celltrion's Steoboclo and Osenvelt (CT-P41; denosumab-bmwo) for all indications of the reference products (Prolia and Xgeva, respectively).

 The approval marks the third for denosumab biosimilars, expanding access to lower-cost biologics for the treatment of osteoporosis and bone metastases.

Denosumab is a monoclonal antibody that inhibits the RANKL protein, a key driver of bone breakdown, helping to prevent bone loss, strengthen bones, enhance bone density, and reduce the risk of fractures in patients with osteoporosis and bone metastases. | Image credit: crevis - stock.adobe.com

Denosumab is a monoclonal antibody that inhibits the RANKL protein, a key driver of bone breakdown. By preventing bone loss, it strengthens bones, enhances bone density, and reduces the risk of fractures in patients. 

These products are usually approved under 2 distinct names, each linked to a specific indication. Stoboclo corresponds with Prolia, which is prescribed for osteoporosis patients, while Osenvelt references Xgeva, used for treating and preventing bone fractures in patients at higher risk due to bone metastases.

The fresh approval comes nearly a year after the first approval for a denosumab biosimilar.

 Wyost and Jubbonti (denosumab-bddz) were approved in early March 2024, and Ospomyv and Obodence (denosumab-dssb) in February 2025.

Additionally, the European Commission granted approval for Stoboclo and Osenvelt in late February 2025.

The approval was based on robust evidence from a phase 3 trial (NCT04757376) over 78 weeks evaluating the efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of CT-P41 vs reference denosumab.

 The study was a double-blind, randomized, active-controlled clinical trial conducted at 20 sites across 4 countries.

Researchers studied 440 postmenopausal women with osteoporosis and found that CT-P41 and US-sourced denosumab were equally effective in improving lumbar spine bone mineral density (BMD) at week 52. Both treatments also showed similar improvements in hip and femoral neck BMD, fracture rates, and quality of life scores.

Safety profiles were comparable, demonstrating a low incidence of antidrug antibodies and serious adverse events. However, limitations included smaller sample sizes in some groups and external disruptions that impacted patient visits and dosing. Despite these, the findings support CT-P41 as a safe and effective alternative to US-sourced denosumab.

"Biosimilars have expanded into new therapeutic areas such as immunology, oncology and ophthalmology as they continue to offer significant cost-saving potential while expanding patient access. Having a denosumab product with a clinically proven track record in quality and safety is a valuable addition for my patients," Jean-Yves Reginster, MD, PhD, director of the WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging, said in a statement.

Stoboclo and Osenvelt are anticipated to launch in the US in June 2025 as part of a settlement agreement with Amgen, the reference product manufacturer.

1. Celltrion receives U.S. FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt

 (denosumab-bmwo) biosimilars referencing Prolia and Xgeva. Press release. Celltrion; March 3, 2025. Accessed March 4, 2025. 

https://www.prnewswire.com/news-releases/celltrion-receives-us-fda-approval-for-stoboclo-denosumab-bmwo-and-osenvelt-denosumab-bmwo-biosimilars-referencing-prolia-and-xgeva-302390957.html 

2. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars

. February 17, 2025. Accessed March 4, 2025. 

https://www.centerforbiosimilars.com/view/fda-ema-approve-second-pair-of-denosumab-biosimilars

3. Jeremais S. FDA approves first denosumab biosimilars. The Center for Biosimilars. March 5, 2024. Accessed March 4, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

4. Jeremias S. EC approves Celltrion denosumab, aflibercept biosimilars. The Center for Biosimilars. February 20, 2025. Accessed March 4, 2025. 

https://www.centerforbiosimilars.com/view/ec-approves-celltrion-denosumab-aflibercept-biosimilars

5. Jeremias S. Equivalence confirmed: CT-P41 paves the way for affordable osteoporosis care. The Center for Biosimilars. January 8, 2025. Accessed March 4, 2025. 

https://www.centerforbiosimilars.com/view/equivalence-confirmed-ct-p41-paves-the-way-for-affordable-osteoporosis-care

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

FDA Approves Third Pair of Denosumab Biosimilars

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

On February 17, the FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

 Two insulin glargine biosimilars, Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr), were previously approved, making Merilog the third overall insulin biosimilar to be greenlit by the FDA. 