Biosimilar Development News

  1. ranibizumab Biosimilar Epruvy Launched In Germany 11/20/2025

    Formycon AG and Bioeq AG (“Bioeq”) jointly announce an agreement with Sandoz AG (“Sandoz”) for the commercialization of Epruvy in Germany.

  2. AcariaHealth Highlights National Biosimilars Education Efforts With Three Events 11/20/2025

    AcariaHealth, a leading specialty pharmacy and a company of Centene Corporation (NYSE: CNC), announced the completion of three national educational events in October focused on the evolving U.S. biosimilars landscape.

  3. Alvotech And Advanz Pharma Receive Marketing Approval Across The European Economic Area For Gobivaz®, A First-In-Market Biosimilar To Simponi® (golimumab) 11/20/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).

  4. Accord BioPharma, Inc. Announces FDA Approval Of Denosumab Biosimilars OSVYRTI® (denosumab-desu) And JUBEREQ® (denosumab-desu) 11/20/2025

    Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) approval of OSVYRTI® (denosumab-desu), a biosimilar to Prolia® (denosumab), and JUBEREQ® (denosumab-desu), a biosimilar to Xgeva® (denosumab).1-2

  5. AEON Biopharma Announces First Closing Of PIPE Investment And Provides Update On FDA Type 2a Meeting Scheduling 11/20/2025

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, today announced the first closing of its previously announced private placement (“PIPE”).

  6. Xbrane Updates On Timing For Resubmission Of The BLA For Its ranibizumab Biosimilar Candidate To FDA 11/19/2025

    Xbrane received a Complete Response Letter (CRL) to the BLA for its investigational biosimilar candidate to LUCENTIS (ranibizumab) from the FDA in October 2025.

  7. Community Oncology Alliance Issues Position Statement On Biosimilars 11/18/2025

    The Community Oncology Alliance (COA) Board of Directors has issued a new position statement supporting policies that advance biosimilar development and uptake while maintaining rigorous clinical standards.

  8. Celltrion Announces European Commission Approval Of Additional Line Extension For Omlyclo 300mg 11/17/2025

    The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion’s Omlyclo (omalizumab), Europe’s first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS).

  9. Sandoz Launches TYRUKO (natalizumab-sztn) In US, As First And Only Multiple Sclerosis Biosimilar 11/17/2025

    Sandoz the global leader in affordable medicines, today announced that TYRUKO (natalizumab-sztn) is available to patients in the US. Developed by Polpharma Biologics, TYRUKO is the first and only US Food and Drug Administration (FDA) approved natalizumab biosimilar for the treatment of relapsing forms of multiple sclerosis (MS).

  10. Polpharma Biologics Confirms U.S. Launch Of Tyruko (natalizumab), The First And Only Biosimilar For Multiple Sclerosis 11/17/2025

    Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, today confirmed that Sandoz Tyruko (natalizumab-sztn) is now available to patients in the United States.