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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability.

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

Laura is the editorial director of The American Journal of Managed Care

) and all its brands, including The American Journal of Accountable Care

, Evidence-Based Oncology™, and The Center for Biosimilars

, since 2011. She has an MA in business and economic reporting from New York University.

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.

Australian Study Reveals Significant Cost Savings and Market Impact From Biosimilars

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

A new biosimilar, SYSA1902, shows comparable efficacy and safety to ustekinumab for treating moderate-to-severe plaque psoriasis, expanding patient options.

SYSA1902 Biosimilar Proves Equivalent to Reference Ustekinumab in Plaque Psoriasis

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Patients with inflammatory bowel disease (IBD) who transitioned from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and generated substantial drug cost savings, according to a single-center 

 from Galway University Hospitals in Ireland.

Biologic therapies such as adalimumab account for a large portion of pharmaceutical expenditures, and biosimilars have been introduced as lower-cost alternatives with comparable efficacy and safety. In Ireland, national health authorities recommend nonmedical switching to biosimilars to improve affordability and expand access. Despite these policy shifts, concerns remain that a “

”—in which patients anticipate worse outcomes due to their negative perceptions about a drug

—could undermine confidence in biosimilars. Researchers sought to explore these clinical, psychological, and economic dynamics during a structured switch to Amgevita.

Seventy-one individuals with IBD were initially recruited, of whom 64 were included in the final analysis. Participants ranged in age from 18 to 67 years, with an average disease duration of 12 years and mean Humira use of nearly 4 years. Most participants had Crohn disease (78%), while others had ulcerative colitis (17%) or indeterminate colitis (5%). Clinical status was measured with standard indices, including the Harvey–Bradshaw Index and partial Mayo score, as well as fecal calprotectin and C-reactive protein. Patient-reported outcomes included the Inflammatory Bowel Disease Control Questionnaire (IBDCQ) and EQ-5D-5L quality-of-life scale, and psychosocial variables were assessed with validated health anxiety and medication belief instruments.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. Patient-reported symptoms measured by the IBDCQ improved slightly, from 13.3 before switching to 12.5 afterward (

 = .043), though this change was small and of uncertain clinical importance. Quality-of-life measures did not meaningfully change.

Adverse events were reported by 25% of participants, with headaches, joint pain, nausea, fatigue, and injection site reactions among the most common. Importantly, statistical analysis indicated that health anxiety was a strong predictor of adverse event reporting, with each 1-point increase in health anxiety score raising the likelihood of an event by 21% (

 = .0079). Only 2 patients reverted to Humira because of intolerance.

Cost analysis revealed meaningful financial benefits. Switching reduced drug expenditures by €143,958 over 8 weeks for the cohort, amounting to an estimated €864,000 in annual savings. Even after accounting for switching clinic costs (€133 per patient) and unscheduled care needs, net savings averaged €2091 per patient over 2 months.

The authors noted that the structured switching clinic was resource intensive but effective in minimizing uncertainty and ensuring patients received adequate support. They suggested that scaling such clinics could further reduce per-patient costs and improve uptake.

Study limitations included its single-center design, short follow-up period, and open-label structure, which prevented a definitive distinction between true adverse effects and nocebo responses. The lack of blinded comparators and the potential influence of the COVID-19 pandemic on response rates were also acknowledged.

Still, the results reinforce international evidence supporting biosimilar adalimumab as a safe and effective alternative to the reference product. “With biosimilar switching, prescribers may expect some patients to develop new side effects, particularly those with high levels of health anxiety,” the authors wrote.

Overall, the study demonstrated that a nonmedical switch to Amgevita preserved disease control and quality of life while delivering significant cost savings, highlighting the importance of patient education and structured implementation to address psychological factors and optimize outcomes.

1. Rabbitt L, Keogh Á, Duane L, et al. A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. 

. 2025;91(9):2628-2635. doi:10.1002/bcp.70086

2. Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. The Center for Biosimilars

. December 18, 2024. Accessed September 8, 2025. 

https://www.centerforbiosimilars.com/view/13-strategies-to-avoid-the-nocebo-effect-during-biosimilar-switching

Clinical

The Top 5 Biosimilar Articles for the Week of September 1

 of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization.

Number 4: A new biosimilar for aflibercept shows 

 in treating neovascular age-related macular degeneration (nAMD), enhancing patient access to treatment.

 in remission outcomes between etanercept biosimilars and the originator, Enbrel, for rheumatoid arthritis patients.


Number 2: Alvotech, an Iceland-based biosimilar-focused biotech company, marked a significant financial milestone in the 

, swinging from a substantial loss to a net profit, driven by the strong commercial performance of its key biosimilar products.

Number 1: The competitive landscape for bone health treatments in the US has intensified with the 

 of Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), biosimilars to Amgen’s reference products Prolia and Xgeva, respectively.

Here are the top 5 biosimilar articles for the week of September 1, 2025.

The romiplostim biosimilar GP40141 showed equivalent efficacy and was a comparable option to reference romiplostim (Nplate; Amgen) in immune thrombocytopenia (ITP), a rare autoimmune disorder.

confirmed its efficacy and safety, with adverse events (AEs) similar between groups in the study.

The multicenter, single-blind, randomized controlled trial (

) evaluated the biosimilar’s performance in adult patients with persistent or chronic ITP. The results showed the biosimilar romiplostim to be analytically and clinically comparable to its reference drug, a significant finding for both patients and health care systems grappling with rising drug costs.

Immune thrombocytopenia is characterized by the destruction of platelets, which can lead to increased bleeding risks and a reduced quality of life.

 The condition affects approximately 2.9 to 6.4 people per 100,000 adults annually.

 For many, ITP becomes a chronic, lifelong condition requiring sustained management.

Thrombopoietin receptor agonists such as romiplostim have become a cornerstone of ITP treatment by stimulating platelet production. Although effective, the high cost of these therapies, particularly the injectable romiplostim, has been a major barrier to widespread adoption, especially in resource-constrained regions.

“The development of biosimilar romiplostim aims to enhance the accessibility and affordability of this critical therapy, providing a lower-cost alternative that can reduce the financial burden on healthcare systems and improve patient access to essential medications,” the authors wrote.

Early in vitro studies confirmed GP40141’s comparability across 23 quality parameters, the authors explained. Preclinical trials in both rats and cynomolgus monkeys further demonstrated similar pharmacokinetics and pharmacodynamics, reinforcing the biosimilar's profile. A subsequent Phase 1 trial in healthy volunteers also validated its similarity to the reference product.

The phase 3 trial, which is the focus of the new report, confirmed these earlier findings in a population of 136 adults with ITP. The study, funded by GP40141 developer Geropharm, randomized patients 1:1 to receive either GP40141 or reference romiplostim for 26 weeks. The main end point in the trial was the proportion of patients achieving a platelet response (≥ 50 × 10

In the test group, 78% of patients showed platelet response after 10 weeks, compared with 85% in the comparison group. Between groups, the absolute difference in proportion was −0.06 (95% CI, −0.196 to 0.068), which falls within equivalence limits (−0.225 to 0.225). There were no significant differences in durable response rates, bleeding events, or safety profiles between the biosimilar and reference drug groups.

There were a total of 46 AEs in 22 patients reported during the study period in the test group vs 38 AEs affecting 18 patients in the reference drug group. The number of AEs and proportion of patients who experienced AEs did not significantly differ between the groups. The most frequent AE was petechiae, with mucosal bleeding also common. Most cases were mild, the authors noted.

The authors concluded that the biosimilar is not only effective but also safe, with no clinically meaningful differences in terms of quality, biological activity, or efficacy when compared with the reference drug.

The study had several limitations, including an incomparably low number of AEs compared with pivotal studies of romiplostim and its biosimilar. Underreporting cannot be ruled out, the authors explained. The single-blinded nature of the study was another limitation.

“Although the study was single-blinded, all efficacy end points were assessed using objective measures, therefore, the results can be considered reliable,” the authors wrote. “… Our aim was to provide evidence that treatment with biosimilar has equal efficacy and comparable safety, because the safety profile of romiplostim was already described elsewhere.”

1. Melikyan AL, Protsenko EA, Salogub GN, et al. Multicenter single-blind randomized controlled trial of the romiplostim biosimilar. 

. 2025;6(4):e70105. doi:10.1002/jha2.70105

2. Pietras NM, Gupta N, Justiz Vaillant AA, et al. Immune thrombocytopenia. StatPearls [Internet]. Updated May 5, 2024. Accessed August 22, 2025. 

https://www.ncbi.nlm.nih.gov/books/NBK562282/

New research confirms the romiplostim biosimilar GP40141 offers comparable efficacy and safety for treating immune thrombocytopenia, enhancing treatment accessibility.

Biosimilar Romiplostim Shows Equivalence to Reference Product for Chronic ITP

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).

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

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

Business & Practice

Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap

 assessed the safety of the infliximab biosimilar CT-P13 (Inflectra) after switching from the reference product (Remicade) in Japanese patients with Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA). Among patients with CD, 39% experienced at least one uncommon adverse drug reaction (ADR), as well as 50% of patients with UC and 13% with RA. However, most ADRs (94%) were considered not related to CT-P13.

The tumor necrosis factor (TNF)-α inhibitor infliximab is used to treat a variety of immune-mediated inflammatory diseases, including IBD (CD and UC) and RA, in which the cytokine TNF plays a central role. 

 was the first infliximab biosimilar and first biosimilar monoclonal antibody approved in Japan in 2014. Clinical trials and real-world studies have established CT-P13 is similarly effective and safe as the originator, however, according to the authors, there are few studies on long-term CT-P13 treatment in Japan, where patient co-pays for biosimilars and originators are the same.

Data on 220 patients was collected in routine clinical practice at multiple centers in Japan, 123 of whom had CD, 74 with UC, and 23 with RA. Patients were stable on the reference product prior to switching to CT-P13. The study is ongoing with patients continuing to complete annual follow-up visits.

After 2 years of CT-P13 therapy, 48 (39%), 37 (50%), and 3 (13%) patients with CD, UC, and RA reported at least 1 ADR. However, the vast majority (94%) were not related to CT-P13. Most ADRs (74%) were grade 1 or 2. The most frequent classes of ADRs reported were gastrointestinal disorders in 11% of patients with CD, infections and infestations in 20% of patients with UC, and injury, poisoning, and procedural implications in 9% of patients with RA.

Adverse events (AEs) and serious AEs (SAEs) were secondary endpoints of the study. AEs were reported by 59% of patients with CD, 70% of patients with UC, and 30% of patients with RA. Serious AEs were reported by 10%, 13.5%, and 9% of patients. Most AEs were grade 1 or 2 and most SAEs were grade 2 or 3. The most frequent AEs were gastrointestinal disorders in patients with CD (40%) and UC (40.5%), and infections and infestations in patients with RA (17%). Herpes zoster infection and pneumonia in patients with CD and UC and nasopharyngitis in patients with RA were considered to have a “plausible relationship to CT-P13 treatment.” One patient with CD and 4 patients with UC reported infusion-related reactions.

Nineteen patients (9%) discontinued CT-P13 for reasons related to the drug, 4 (9%) with CD, 11 (31%) with UC, and 4 (31%) with RA. The primary reason was loss of efficacy in patients with UC and RA, and AEs in patients with CD. Two patients with CD and 1 with UC experienced SAEs leading to discontinuation of treatment.

The authors concluded that CT-P13 was “well tolerated” over 2 years in this study, as most ADRs were not related to CT-P13, and few patients stopped treatment due to reasons related to the biosimilar. They added that the effectiveness of infliximab therapy was “well maintained,” and said their findings demonstrate long-term safety of CT-P13 in real-world practice. They plan to report 5-year data at the completion of the study.

Ishida T, Yokoe I, Obata H, Park S, Kim S, Nishimata N. A real-world, observational, prospective cohort study evaluating the safety and effectiveness of CT-P13 in inflammatory bowel disease and rheumatoid arthritis: the MEGA-J study. 

. 2025;41(4):601-606. doi:10.1080/03007995.2025.2492638

The MEGA-J study reveals CT-P13's long-term safety and effectiveness in treating inflammatory bowel disease and rheumatoid arthritis, with minimal adverse reactions.

Real-World Data Suggest Long-Term Safety of CT-P13 in IBD, RA

 on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

The requirements for FDA approval of biosimilars are appropriate.

There is no longer any need for comparative clinical efficacy trials.

The requirements for demonstration of biosimilarity need to be increased.

Check out the results from our last poll:

There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

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