Biosimilar Development News

  1. Henlius Enters Into License Agreement With Sandoz For Proposed Ipilimumab Biosimilar 4/29/2025

    On April 29, 2025, Shanghai Henlius Biotech, Inc. announced a licensing agreement with Sandoz, the global leader in generic and biosimilar medicines, granting exclusive commercialization rights for its self-developed ipilimumab biosimilar HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

  2. Bone Health: Biocon Biologics Receives Positive CHMP Opinions For Biosimilar Denosumab In Europe 4/29/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523) (NSE: BIOCON), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the authorization of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo® and Denosumab BBL (brand name is currently under approval).

  3. CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code For Otulfi (ustekinumab-aauz) 4/28/2025

    Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code for Otulfi (ustekinumab-aauz).

  4. CuraTeQ Biologics Receives CHMP Positive Opinion For Dazublys – Trastuzumab Biosimilar 4/26/2025

    CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

  5. AEON Biopharma Appoints Industry Veteran Rob Bancroft As Chief Executive Officer 4/21/2025

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today the appointment of Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. Mr. Bancroft will also join AEON’s Board of Directors.

  6. Biosimilars Forum Applauds The Trump Administration For Drug Pricing Executive Order 4/16/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the Trump Administration’s Executive Order, which promotes the availability and streamlined development of biosimilars.

  7. Biosidus Announces Promising Interim Results From Phase III Study On Agalsidase Beta For Fabry Disease 4/16/2025

    Biosidus, an Argentinean pioneer company in biotechnology research, development, and the production of high-quality biosimilars, has announced encouraging interim results from the Phase III SMILE1 study.

  8. Chime Biologics Partners Polpharma Biologics To Advance Global Biosimilar Development 4/16/2025

    Chime Biologics, a leading global CDMO that enables its partners' success in biologics, is pleased to announce a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and manufacture of a biosimilar product for the global market.

  9. Accord BioPharma, Inc. Announces Completion Of UDENYCA® (pegfilgrastim-cbqv) Franchise Acquisition From Coherus BioSciences, Inc., Expanding U.S. Biosimilar Portfolio 4/15/2025

    Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced today that Intas Pharmaceuticals has completed its acquisition of the UDENYCA® (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc.

  10. U.S. FDA Grants Interchangeable Designation To YUFLYMA® (adalimumab-aaty), Celltrion's Biosimilar To Humira® (adalimumab) 4/15/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab).