Biosimilar Development News

  1. Samsung Bioepis Gains European Commission (EC) Approval For Denosumab Biosimilar (OBODENCE, XBRYK) 2/15/2025

    Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE (60mg pre-filled syringe) and XBRYK (120mg vial), denosumab biosimilars referencing Prolia and Xgeva – formerly referred to as SB16.

  2. FDA Approves First Rapid-Acting Insulin Biosimilar Product For Treatment Of Diabetes 2/14/2025

    Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

  3. Phase 3 MRCT Results Of Denosumab Biosimilar HLX14 Released At ORS 2025 2/12/2025

    On February 11, 2025, the results of the international multicenter phase 3 study (NCT05352516) of denosumab biosimilar candidate HLX14 were released at the 2025 Orthopaedic Research Society (ORS) Annual Meeting.

  4. Bio-Thera Solutions Announces Exclusive Commercialization And License Agreement With Intas Pharmaceuticals For BAT2506, A Proposed Biosimilar Referencing Simponi® (golimumab), In The United States Of America 2/10/2025

    Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America.

  5. Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement With Bio-Thera For BAT2506, A Proposed Golimumab Biosimilar 2/10/2025

    Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and critical care therapies, announced today that it has reached an exclusive commercialization and license agreement with Bio-Thera Solutions ("Bio-Thera") for BAT2506, a biosimilar candidate to Simponi® (golimumab).

  6. Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2506, A Proposed Biosimilar To Simponi®, In The European Union 2/7/2025

    Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi® (golimumab), seeking a commercial license in the European Union(EU).

  7. US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab) 2/2/2025

    Shanghai Henlius Biotech, Inc. announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab).

  8. U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), A Biosimilar To ACTEMRA® 1/30/2025
  9. Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria® (golimumab) 1/27/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions.

  10. Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama 1/21/2025

    Formycon AG and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama.