Biosimilars News Roundup: September 2025

In September 2025, biosimilars continued to demonstrate their global impact, with AAM reporting $20.2 billion in US savings in 2024 despite a concerning development void, new FDA and European approvals expanding access to denosumab and aflibercept therapies, and real-world studies from Australia, Ireland, and China confirming that switching to biosimilars maintains safety and efficacy while reducing costs and enhancing patient access worldwide.

Biosimilar approvals surge in the US and Europe, enhancing access to denosumab and aflibercept therapies while driving significant health care savings.

AAM Report Reveals Startling Development Void Despite Biosimilar Success

Biosimilars generated $20.2 billion in savings in 2024 alone, contributing to a total of $56.2 billion since the first biosimilar entered the US market, according to the Association for Accessible Medicines (AAM).¹ Collectively, generic and biosimilar medicines saved the US health care system $467 billion in 2024, adding to nearly $3.4 trillion in savings over the past decade. Increased biosimilar competition has expanded patient access, providing an estimated 460 million additional days of therapy, and second-to-market biosimilars entering within 3 years of the first have been shown to accelerate price reductions. However, the report highlighted a concerning “biosimilar void,” noting that 90% of biologics expected to lose patent exclusivity over the next decade currently lack a biosimilar in development.

The analysis also underscored ongoing challenges in the generics market. Generics made up roughly 90% of US prescriptions in 2024 yet only 12% of spending, with average out-of-pocket costs for generics remaining far below brand name drugs. Despite consistent savings, the report warned of price deflation creating unsustainable conditions for manufacturers. AAM leaders emphasized that coordinated action across manufacturers, providers, payers, and policymakers is essential to normalize biosimilar adoption, confront systemic barriers, and fully realize the cost and access benefits of these medicines.

American and European Biosimilar Approvals

The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), marking the sixth pair of denosumab biosimilars cleared in the US.² These approvals, granted to Biocon Biologics, expand affordable treatment options for patients with osteoporosis and cancer-related bone conditions. Bosaya, a biosimilar to Prolia, and Aukelso, a biosimilar to Xgeva, were both granted provisional interchangeability and demonstrated comparable quality, safety, and efficacy to their reference products.

Bosaya is indicated for postmenopausal women and men at high risk for fracture, glucocorticoid-induced osteoporosis, and certain patients receiving hormone ablation therapy for nonmetastatic prostate or breast cancer. Aukelso is approved to prevent skeletal-related events in multiple myeloma and bone metastases, treat giant cell tumors of bone, and manage refractory hypercalcemia of malignancy. These approvals continue a rapid expansion of denosumab biosimilars in the US, following 5 prior pairs that have launched since March 2024.

Following the US, the European Commission (EC) granted marketing authorizations for several new biosimilars, expanding affordable treatment options for patients with bone and retinal conditions.³ The approvals include 2 denosumab biosimilars, Bildyos and Bilprevda, from Organon and Shanghai Henlius Biotech, which are biosimilars to Prolia and Xgeva, respectively.

In addition, Germany-based STADA Arzneimittel received EC approval for Afiveg, an aflibercept biosimilar to Eylea, indicated for multiple retinal diseases including wet age-related macular degeneration. Afiveg marks STADA’s second ophthalmology biosimilar and eighth biosimilar overall in Europe, with a planned launch in Germany in Q4 2025. STADA executives emphasized the approvals as a way to expand patient access while supporting sustainable health care, building on the company’s growing specialty biosimilar portfolio.

Building Global Trust in Biosimilar Safety and Cost-Effectiveness

A recent study in Value in Health Regional Issues highlighted the economic impact of biosimilars on the Australian health care system, demonstrating their role in reducing costs and driving price competition.⁴ Using a decade of sales data (2010-2020), researchers found that just 12 months after biosimilar entry, expenditure for reference biologics dropped by 38%, whereas per-unit prices fell 30% to 40%. Biosimilars themselves were priced up to 40% lower than reference products, and by 2020 they accounted for 30% of Australia’s biologics market. These findings emphasize that cost savings were primarily driven by price reductions rather than changes in overall use.

The study also underscored the importance of timing, policy, and clinician confidence for biosimilar adoption, with newer introductions like rituximab and trastuzumab capturing higher market shares than earlier entrants. Although patient-level uptake remains limited, with many unaware of biosimilar options, evidence shows that specialist recommendations strongly influence acceptance.

A prospective cohort study at Galway University Hospitals in Ireland found that patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and quality of life.⁵ Objective measures, including biomarkers and disease activity indices, showed no significant changes after the switch, and patient-reported symptoms improved slightly. Adverse events were generally mild, with only 2 patients reverting to Humira due to intolerance, and health anxiety was identified as a key predictor of perceived side effects.

The structured switching clinic also generated substantial cost savings, reducing drug expenditures by €143,958 over 8 weeks for the cohort, translating to an estimated €864,000 annually. Even after accounting for clinic costs and unscheduled care, net savings averaged €2,091 per patient. The study highlights that biosimilar switching can be safe, effective, and financially beneficial, particularly when accompanied by patient education and structured support to address psychological factors and optimize outcomes.

A real-world study from Fudan University Shanghai Cancer Center found that HLX02, a trastuzumab biosimilar, was as safe and effective as the originator in patients with HER2-positive metastatic breast cancer, including those who switched mid-treatment.⁶ Among 124 women, response rates and progression-free survival were comparable regardless of whether patients started on HLX02 or switched from Herceptin. Safety outcomes were consistent with prior clinical trials, and no new concerns emerged. The study reinforces HLX02 as a cost-effective option that could expand treatment access in resource-limited settings.

Recent regulatory and reimbursement milestones are broadening access to aflibercept biosimilars for retinal diseases worldwide.⁷ In the US, Sandoz settled patent disputes with Regeneron, clearing the path for Enzeevu to launch in late 2026. In Europe, Alteogen’s Eyluxvi received EC approval for multiple ophthalmic indications, demonstrating comparable efficacy and safety to Eylea in phase 3 trials. Meanwhile, Canada’s Ontario Drug Benefit Formulary added Biocon Biologics’ Yesafili, enabling public funding for over 2 million patients with retinal conditions. These developments collectively enhance global access to affordable, effective biosimilar therapies for vision-threatening diseases.

References

1. Jeremias S. Biosimilars drive savings and access, yet looming development gap threatens future. The Center for Biosimilars^®. September 23, 2025. Accessed September 23, 2025. https://www.centerforbiosimilars.com/view/biosimilars-drive-savings-and-access-yet-looming-development-gap-threatens-future

2. Jeremias S. FDA approves Biocon Biologics' denosumab biosimilars: Bosaya and Aukelso. The Center for Biosimilars. September 18, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/fda-approves-biocon-biologics-denosumab-biosimilars-bosaya-and-aukelso

3. Jeremias S. EC approves new biosimilars for bone and eye conditions. The Center for Biosimilars. September 19, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/ec-approves-new-biosimilars-for-bone-and-eye-conditions

4. Jeremias S. Australian study reveals significant cost savings and market impact from biosimilars. The Center for Biosimilars. September 10, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/australian-study-reveals-significant-cost-savings-and-market-impact-from-biosimilars

5. Jeremias S. Switch to biosimilar adalimumab found safe and cost-saving for patients with IBD. September 9, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/switch-to-biosimilar-adalimumab-found-safe-and-cost-saving-for-patients-with-ibd

6. Jeremias S. Real-world evidence supports biosimilar HLX02 in metastatic breast cancer. The Center for Biosimilars. September 11, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/real-world-evidence-supports-biosimilar-hlx02-in-metastatic-breast-cancer

7. Jeremias S. Global aflibercept biosimilar progress signals rising access for retinal disease care. The Center for Biosimilars. September 22, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/global-aflibercept-biosimilar-progress-signals-rising-access-for-retinal-disease-care