Biosimilars News Roundup: Approvals Surge Amid Policy Changes

November 2025 marked a period of significant activity in the biosimilar market, characterized by multiple FDA approvals and crucial policy discussions concerning market access and regulatory modernization. Key themes included the expansion of competition in oncology and bone health, global efforts toward regulatory harmonization, and intense scrutiny of US market barriers.

Major FDA Approvals Expand Competition

The month saw major advancements in product approvals and interchangeability designations, particularly for denosumab and pertuzumab biosimilars.

The FDA approved multiple denosumab biosimilars throughout the fall, bolstering competition in therapies used for postmenopausal osteoporosis (referencing Prolia) and prevention of skeletal-related events in cancer (referencing Xgeva).¹ This momentum included the formal granting of interchangeability (IC) designations to 2 pairs of products in late October: Fresenius Kabi's Conexxence and Bomyntra, and Celltrion’s Stobocclo and Osenvelt (denosumab-bmwo). Interchangeability status allows pharmacists to substitute these products for their reference biologics without prescriber approval, subject to state laws.

Further expanding the oncology pipeline, the FDA approved Poherdy (pertuzumab-dpzb) injection on November 18, making it the first interchangeable biosimilar for Perjeta (pertuzumab).² Developed by Shanghai Henlius Biotech and commercialized by Organon, Poherdy is approved for all the same indications as Perjeta, including use in combination with trastuzumab and chemotherapy for HER2-positive metastatic, locally advanced, or early-stage breast cancer. The approval was based on evidence demonstrating that Poherdy is highly similar to Perjeta with no clinically meaningful differences. Despite this regulatory success, the product immediately faced patent litigation, as the originator manufacturers filed a complaint alleging infringement on 24 patents.

Global Biosimilars Week Focuses on Access

The sixth annual Global Biosimilars Week (November 3 to 7, 2025) included a webinar, "Aligning Biosimilar Access Policy With Global Health Priorities," which explored how biosimilars can help meet the UN’s Sustainable Development Goals for Health by 2030.³

Lisa Hedman of the World Health Organization (WHO) noted that progress toward the WHO target of 80% biosimilar availability is uneven across regions, with public sector availability ranging from 38% to 68%. Julie Maréchal-Jamil of Medicines for Europe highlighted that regulatory convergence initiatives are key drivers for access, stressing the need for a global regulators roadmap toward tailored clinical development. She cautioned that the asynchronous adoption of new regulatory standards might force developers to maintain extended timelines or develop separate programs for different jurisdictions. Separately, in Mexico, where biosimilars are called biocomparables, current local rules still require clinical trials to demonstrate efficacy and safety, determined case-by-case by the New Molecules Committee.

Policy Updates: Regulatory Reform and Economic Impact

Policy discussions in November centered on bridging the gap between regulatory reforms and real-world market uptake.

In the podcast episode "All Things Biosimilars: How Streamlined CES Rules Could Shift the Market," Giuseppe Randazzo and Alex Keeton of the Association of Accessible Medicines (AAM) analyzed the FDA’s draft guidance on comparative efficacy studies (CES) and interchangeability.⁴ The guidance seeks to streamline development by reducing or eliminating the need for large, costly CES, instead recognizing the scientific value of advanced analytical tools and pharmacokinetic data. This regulatory evolution could save manufacturers years of development time and an estimated $100 million to $300 million per program.

The hosts noted that while this shift supports competition, Congressional action is still needed to resolve policy gaps, particularly regarding the continuing existence of the interchangeable designation and restrictive state-level substitution laws. They also brought attention to the "biosimilar void," highlighting that over 100 biologics are nearing patent expiration without biosimilars in active development.

The general consensus across policy articles was that changing FDA interchangeability standards, while necessary, is likely insufficient to optimize US biosimilar competition.⁵ Additional steps needed include amending state pharmacist substitution laws, addressing strategies by payers and pharmacy benefit managers that inhibit competition (such as rebate walls), and enhancing education to build confidence among clinicians and patients.

Rounding out the month's news, an economic analysis underscored the tangible financial benefits of biosimilar uptake.⁶ A budget impact analysis evaluated the potential financial implications of adopting biosimilar denosumab within a US health plan, projecting substantial cost savings for payers. In a base case scenario, the model projected a 5-year net savings of over $38.6 million.

Furthermore, the study modeled how reinvesting those savings could expand patient access, predicting that using savings to treat patients previously receiving zoledronic acid could allow for the treatment of nearly 1,000 additional patients over 5 years, thereby preventing 28.2 additional skeletal-related events. These findings suggest that biosimilar denosumab offers a pathway to reduce the total cost of care in oncology while potentially improving patient access to essential supportive therapy.

References

1. Jeremias S. FDA quietly approves denosumab biosimilars, issues interchangeability for others. The Center for Biosimilars^®. November 13, 2025. https://www.centerforbiosimilars.com/view/fda-quietly-approves-denosumab-biosimilars-issues-interchangeability-for-others

2. Jeremias S. FDA approves Poherdy: the first interchangeable biosimilar to Perjeta. The Center for Biosimilars. November 18, 2025. https://www.centerforbiosimilars.com/view/fda-approves-poherdy-first-interchangeable-biosimilar-to-perjeta

3. Jeremias S. Webinar: aligning biosimilar access policy with global health priorities. The Center for Biosimilars. November 14, 2025. https://www.centerforbiosimilars.com/view/webinar-aligning-biosimilar-access-policy-with-global-health-priorities

4. Jeremias S, Randazzo G, Keeton A. All things biosimilars: how streamlined CES rules could shift the market. The Center for Biosimilars. November 30, 2025. https://www.centerforbiosimilars.com/view/all-things-biosimilars-how-streamlined-ces-rules-could-shift-the-market

5. Rome BN, Bhaskar A, Kesselheim AS. Biosimilar interchangeability and substitution in the US: what comes next? The Center for Biosimilars. November 27, 2025. https://www.centerforbiosimilars.com/view/biosimilar-interchangeability-and-substitution-in-the-us-what-comes-next-

6. Jeremias S. Economic analysis supports the formulary shift to biosimilar denosumab. The Center for Biosimilars. November 26, 2025. https://www.centerforbiosimilars.com/view/economic-analysis-supports-formulary-shift-to-biosimilar-denosumab