Biosimilar Development News

  1. First Patient Dosed In China For International Multi-Centre Phase 1 Clinical Trial Of Henlius' Nivolumab Biosimilar HLX18 7/16/2026

    Henlius (2696.HK) announced that the first patient in China has been dosed in the international multicenter Phase 1 clinical trial (HLX18-MRST001) of its self-developed nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) in patients with resected solid tumors.

  2. Samsung Bioepis And Organon Broaden Biosimilar Access In Australia Through Expanded Commercialisation Agreement 7/16/2026

    Samsung Bioepis Co., Ltd. and Organon, a global healthcare company with deep expertise in biosimilars, have announced the expansion of their Development and Commercialisation Agreement, to commercialise a new biosimilar in Australia by Organon ANZ.

  3. The Biosimilars Council And AAM Applauds House Introduction Of The Expedited Access To Biosimilars Act 7/15/2026

    The Biosimilars Council and the Association for Accessible Medicines today applauded legislation, the Expedited Access to Biosimilars Act, introduced this week in the U.S. House of Representative by Congressman Nick Langworthy (NY-23) and Congresswoman Kim Schrier, M.D. (WA-08), to codify FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies.

  4. Formycon And OneSource Specialty Pharma Announce Strategic Manufacturing Partnership For Biosimilars 7/14/2026

    Formycon AG and OneSource Specialty Pharma Limited, a multi-modality specialty pharma CDMO, today announced a strategic manufacturing partnership for biosimilars.

  5. First Patient Dosed In The U.S. For International Multi-Center Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC 7/13/2026

    Shanghai Henlius Biotech, Inc. today announced that the first patient in the U.S. has been dosed in the international multi-center Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM).

  6. Biocon Announces Publication Of Pivotal Clinical Data Supporting Effectiveness Of Yesafili, A Biosimilar To Eylea (Aflibercept) 7/9/2026
  7. Teva And Samsung Bioepis Enter Commercialization Agreement For OPUVIZ®, a Biosimilar Referencing Eylea® (aflibercept), In Canada 7/9/2026

    Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) and Samsung Bioepis Co., Ltd. today announced that the companies have entered into a license and commercialization agreement for OPUVIZ® (aflibercept), a biosimilar referencing Eylea®1 (aflibercept), in Canada.

  8. FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar To NEULASTA® (pegfilgrastim) 7/9/2026

    Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim).

  9. Teva And Polpharma Biologics Announce Global Licensing Agreement For A Biosimilar Candidate To Ocrevus (Ocrelizumab) For Multiple Sclerosis 7/9/2026

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd and Polpharma Biologics International AG today announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus1 (ocrelizumab), upon regulatory approval.

  10. First Patient Dosed In China For Phase 1 Clinical Trial Of Henlius' Cetuximab Biosimilar HLX05-N 7/8/2026

    Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in China in the phase 1 clinical trial (HLX05-N-mCRC102) of its independently developed cetuximab biosimilar, HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for the treatment of metastatic colorectal cancer (mCRC).