Biosimilar Development News

  1. Biocon Biologics Secures Market Entry Date For Denosumab Biosimilars In Europe And Rest Of The World 12/2/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. today announced a settlement agreement with Amgen Inc.

  2. Celltrion Announces U.S. FDA Approval Of 300mg Strength Of OMLYCLO® (omalizumab-igec), The First And Only FDA-Approved Interchangeable Biosimilar To XOLAIR® 12/2/2025

    Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection.

  3. Accord Healthcare Announces Launch Of Denosumab∇ - Second Biosimilar In Bone Health 12/2/2025

    Accord Healthcare today announced the launch of Osvyrti (denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (denosumab), a biosimilar to Xgeva® (Amgen), following the scheduled expiry of the reference medicine's patent on 27 November 2025.

  4. Zentiva Expands Into Biologics With The EU-Wide Launch Of Its First Biosimilar 12/1/2025

    Zentiva, a leading European manufacturer of affordable, high-quality medicines, today announced the first EU-wide launch of a monoclonal antibody biosimilar, following approval by the European Medicines Agency (EMA).

  5. Samsung Bioepis Announces Launch Of Denosumab Biosimilars, OBODENCE And XBRYK, In Europe 12/1/2025

    Samsung Bioepis Co., Ltd. today announced the launch of OBODENCE (60 mg pre-filled syringe) and XBRYK (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva.

  6. Lupin Receives Approval From U.S. FDA For Biosimilar Armlupeg (pegfilgrastim-unne) 12/1/2025

    Global pharma major Lupin Limited (Lupin), today announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection.

  7. Sandoz Launches Denosumab Biosimilars In Europe, Providing Affordable Treatment Option For Cancer-Related Bone Disease And Osteoporosis For Millions Of Patients 12/1/2025

    Sandoz the global leader in affordable medicines, today announced the European launch of Wyost (denosumab 120 mg) and Jubbonti (denosumab 60 mg).

  8. Prestige Biopharma And Biosidus Enter Exclusive License Agreement For Tuznue® Commercialization In Latin America 11/26/2025

    Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay.

  9. Saya Biologics And Innovent Biologics Announce Strategic Collaboration To Expand Access To Oncology Therapies In Mexico 11/26/2025

    Saya Biologics (Saya Bio), a Mexican biopharmaceutical company focused on expanding access to innovative, high-quality and affordable biologic treatments, and Innovent Biologics, a global company specializing in the development and manufacturing of biologic therapies, have announced a strategic collaboration to register, launch, and commercialize an oncology biosimilar in Mexico, aiming to broaden the therapeutic options available to patients.

  10. Teva Receives European Commission Approvals For PONLIMSI® (denosumab) Biosimilar To Prolia® And DEGEVMA® (denosumab) Biosimilar To Xgeva® 11/25/2025

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced that the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar candidates – PONLIMSI, a biosimilar to Prolia®1 and DEGEVMA, a biosimilar to Xgeva®, following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) earlier this year.