Biosimilar Development News

  1. 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).

  2. 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.

  3. 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.

  4. Celltrion Receives Health Canada Approval For Eydenzelt, A Biosimilar Referencing Eylea (aflibercept 2mg) 11/27/2025

    Celltrion, Inc. today announced that Health Canada has approved Eydenzelt, a biosimilar referencing Eylea (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea.1

  5. 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.

  6. 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.

  7. 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.

  8. Sandoz Launches Afqlir (aflibercept) In Europe, Providing Affordable Treatment Option For Patients With Retinal Diseases 11/24/2025

    Sandoz the global leader in affordable medicines, today announced the European launch of Afqlir (aflibercept). Afqlir, a 2 mg vial kit and pre-filled syringe for intravitreal injection, was approved by the European Commission in November 2024 for the same indications in adult patients as the reference medicine, Eylea***, namely the treatment of various retinal diseases to prevent disease-related blindness1,2.

  9. NTC Becomes Commercialization Partner For Formycon's Eylea Biosimilar FYB203/Baiama In Italy 11/24/2025

    Formycon AG and NTC s.r.l. (“NTC”) jointly announce that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), concluded an exclusive agreement with NTC for the commercialization of FYB203/Baiama2 in Italy.

  10. Alvotech Announces Approval Of AVT03, A Biosimilar To Prolia® And Xgeva® (denosumab) In The European Economic Area 11/24/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab).