Biosimilar Development News

  1. Formycon And MS Pharma Sign Exclusive Commercialization Partnership For Keytruda® Biosimilar Candidate FYB206 For The MENA Region 12/4/2025

    Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon's biosimilar candidate to the blockbuster drug Keytruda®[1] (pembrolizumab), in the Middle East and North Africa ("MENA region"). The agreement includes an option for future technology transfer.

  2. mAbxience And HP Drive The Use Of Artificial Intelligence In Biomanufacturing And Biosimilar Development 12/4/2025

    mAbxience, a Fresenius entity, and HP Inc., a global leader in technology, announce a new project to develop an innovative artificial intelligence (AI) solution that optimizes the production process of monoclonal antibodies and biosimilars.

  3. 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.

  4. Pre-Filled Syringe Presentation Of BYOOVIZ, Samsung Bioepis' Biosimilar To Lucentis (Ranibizumab), Gains European Approval 12/2/2025

    Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS), a biosimilar referencing Lucentis1 (ranibizumab).

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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).