Biocon Biologics Secures Market Entry Date for Denosumab Biosimilars in Europe and Global Markets
Biocon Biologics entered into a settlement agreement with Amgen Inc. allowing commercialization of its Denosumab biosimilars, Vevzuo and Evfraxy, in Europe and the rest of the world starting December 2, 2025.15
The European Commission granted marketing authorization for Vevzuo and Evfraxy biosimilars in July 2025, following positive opinions from the European Medicines Agency’s CHMP in April 2025.367
This settlement and approvals expand Biocon Biologics' presence in oncology and bone health therapeutic areas and follow a similar settlement in the U.S. in October 2025, where Biocon secured market entry dates for Bosaya and Aukelso biosimilars.159
The marketing authorization allows Biocon Biologics to commercialize these biosimilars across all EU member states and the European Economic Area (EEA).46
Clinical data demonstrated comparable safety, efficacy, pharmacokinetics, and immunogenicity profiles of Biocon’s biosimilars relative to the reference product (Amgen’s Denosumab).36
The settlement terms beyond the market entry dates remain confidential.15
Biocon Biologics is leveraging this market entry to expand affordable biologic access globally, addressing over 6 million patients across 120+ countries.5
Sources:
1. https://www.businesstoday.in/markets/stocks/story/biocon-biologics-secures-market-entry-date-for-denosumab-biosimilars-in-europe-rest-of-world-504542-2025-12-02
3. https://www.bioconbiologics.com/biocon-biologics-receives-positive-chmp-opinions-for-biosimilar-denosumab-in-europe/
4. https://www.biocon.com/docs/SE-NotificationBiocon-BiologicsMHRA-Denosumab-Approval_July7.pdf
5. https://www.bioconbiologics.com/biocon-biologics-secures-market-entry-date-for-denosumab-biosimilars-in-europe-and-rest-of-the-world/
6. https://www.biocon.com/advancing-bone-health-european-commission-approves-biocon-biologics-denosumab-biosimilars/
7. https://www.bigmoleculewatch.com/2025/07/29/biocon-regulatory-approval-updates-in-the-u-s-and-europe-insulin-aspart-and-denosumab/
9. https://www.goodwinlaw.com/en/insights/blogs/2025/09/fda-approves-biocons-denosumab-biosimilars