Biosimilars News Roundup: July 2025

The past month has seen significant developments in the biosimilar landscape, ranging from legislative proposals to combat market access barriers to new product approvals and ongoing challenges related to public and professional understanding. Here's a concise roundup of the key biosimilar news from July 2025.

Addressing Patent Thickets to Boost Access

A new report from the Association for Accessible Medicines (AAM) highlighted patent thickets as a major obstacle to biosimilar access, which drives up costs and delays affordable treatments.¹ These "excessive webs of secondary patents" are filed by branded manufacturers to extend market exclusivity, leading to complex and costly litigation. US litigation involves a staggering number of asserted patents (11 to 65 per product), far exceeding other countries.

The AAM report proposed 3 legislative solutions: capping the number of asserted patents in biologic patent litigation, allowing biosimilar manufacturers freedom to settle litigation procompetitively, and providing a statutory safe harbor for carve-outs of patented methods of treating diseases. The authors argued that these changes will reduce litigation delays, limit patent abuse, and promote timely market entry, ultimately lowering health care costs and improving patient access.

Global Biosimilar Approvals Expand Treatment Options

Recent weeks have demonstrated global momentum in biosimilar regulatory advancements, with key approvals and positive opinions in the US, Europe, and Canada.² The FDA accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi, intended for various autoimmune conditions.

In Europe, Alteogen received a positive opinion from the EMA for Eyluxvi (ALT-L9), a biosimilar to Eylea, for ophthalmic conditions like wet age-related macular degeneration. The European Commission also approved Denbrayce and Izamby, denosumab biosimilars referencing Xgeva and Prolia, respectively, for bone-related conditions and osteoporosis.

Canada also saw approvals for Aflivu and Yesafili, both biosimilars to Eylea. These approvals signify enhanced access to affordable, high-quality therapeutic options.

White Paper Offers Solutions to Avert a Biosimilar Market Void

After a previous report warned of a potential "biosimilar void," where 90% of biologics losing exclusivity in the next decade lack biosimilars in development, a new white paper from Samsung Bioepis proposes urgent policy reforms to ensure market sustainability, including:³

• Introducing free pricing at launch for biosimilars.
• Implementing multi-winner tenders to diversify supply.
• Linking biosimilar pricing to comprehensive health technology assessments.
• Establishing minimum price boundaries to prevent excessive price erosion.
• Promoting collaborative frameworks across Europe for harmonized policies. The report also highlights persistent skepticism among prescribers and patients, emphasizing the need for targeted education to build confidence.

The report warned that current pricing and reimbursement policies often undermine biosimilar sustainability. Mandated price cuts at launch and rigid reimbursement rules can distort competition and deter investment. Instead, the authors advocated for more flexible, market-based pricing models that allow biosimilars to compete on value rather than cost alone.

Medicare Price Negotiations May Slow Biosimilar Momentum

A report from Matrix Global Advisors suggested that government price negotiations under the Inflation Reduction Act may unintentionally hinder biosimilar development, potentially widening a "biosimilar void."⁴ Despite the IRA's goal to rein in high drug costs, the threat of negotiations may deter manufacturers from launching biosimilars, especially for high-sales biologics, risking billions in potential annual savings if biosimilar entry is delayed. The report advocated for fostering competitive markets rather than suppressing biosimilar entry through government pricing, stressing the need to address anticompetitive behaviors like patent thickets.

Insulin Biosimilar Gains in a Growing Market

The FDA approved Kirsty (insulin aspart-xjhz) as the first rapid-acting interchangeable biosimilar product to Novolog (insulin aspart).⁵ This is a crucial step towards enhancing access to more affordable insulin for millions of Americans with diabetes. The "interchangeable" designation allows Kirsty to be substituted for Novolog at the pharmacy without a new prescription in states where laws permit it, further streamlining patient access and driving competition. This approval follows Merilog (insulin-aspart-szjj), the first insulin aspart biosimilar, and two insulin glargine products.

Separately, a recent narrative review underscored persistent concerns among health care providers and patients regarding the efficacy, safety, and quality of biosimilar insulins compared with reference products.⁶ The review dissected the regulatory pathways in the European Union and the US, still ultimately confirming the safety and efficacy of insulin biosimilars. Researchers detailed the necessity of comparative analytical, functional, preclinical, and pivotal clinical pharmacology studies for approval.

Knowledge Gaps Hinder Biosimilar Adoption

Despite the growing presence of biosimilars, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).⁷ A study using mock advertisements for a fictitious biosimilar found that overall comprehension of biosimilar information was suboptimal, with only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs accurately understanding core characteristics like comparable safety and efficacy.

The study noted that expanded definitions led to more positive attitudes and stronger prescribing intentions for HCPs, and both groups preferred more detailed definitions. These findings underscore an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of biosimilars, which is vital for realizing their cost-saving benefits and expanding treatment access.

References

1. Jeremias S. Clearing the thicket: new report outlines legislative fixes to boost biosimilar access. The Center for Biosimilars^®. July 29, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/clearing-the-thicket-new-report-outlines-legislative-fixes-to-boost-biosimilar-access

2. Jeremias S. New approvals expand access to biosimilars for ophthalmology, bone, and joint conditions. The Center for Biosimilars. July 28, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/new-approvals-expand-access-to-biosimilars-for-ophthalmology-bone-and-joint-conditions

3. Jeremias S. Medicare price negotiations will slow biosimilar momentum, widening market gap. The Center for Biosimilars. July 16, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap

4. Jeremias S. White paper offers tips for sustaining biosimilar progress, avoiding a market void. The Center for Biosimilars. July 15, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/white-paper-offers-tips-for-sustaining-biosimilar-progress-avoiding-a-market-void

5. Jeremias S. FDA approves Kirsty as first interchangeable insulin aspart biosimilar. The Center for Biosimilars. July 15, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/fda-approves-kirsty-as-first-interchangeable-insulin-aspart-biosimilar

6. Jeremias S. Dispelling doubts: review affirms safety, efficacy of biosimilar insulins. The Center for Biosimilars. July 8, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/dispelling-doubts-review-affirms-safety-efficacy-of-biosimilar-insulins

7. Jeremias S. Consumers and providers face biosimilar knowledge hurdles. The Center for Biosimilars. July 7, 2025. Accessed July 31, 2025. https://www.centerforbiosimilars.com/view/consumers-and-providers-face-biosimilar-knowledge-hurdles