Biosimilar Development News

  1. 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.

  2. 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).

  3. STADA Obtains Approvals To Bring denosumab Biosimilars In Bone-Health And Oncology To Patients In Europe 11/24/2025

    STADA has received marketing authorisations from the European Commission (EC) for its Kefdensis and Zvogra denosumab biosimilars.

  4. 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.

  5. 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.

  6. 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).

  7. 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

  8. 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”).

  9. 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.

  10. 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.