Biosimilar Development News

  1. Brazil Achieves A Historic Milestone: Blau Farmacêutica Fully Develops One Of The World's Most Advanced Biosimilars Immunotherapies 1/23/2026

     Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an important achievement for science, healthcare, and the bio-pharmaceutical industry in Brazil: the fully integrated development in Brazil of a pembrolizumab biosimilar, one of the most widely used and advanced immunotherapies for the treatment of multiple types of cancer.

  2. Over Three Dozen Groups Join The Biosimilars Council And AAM To Reiterate Support For Interchangeability Legislation 1/22/2026

    The Biosimilars Council and the Association for Accessible Medicines sent a follow up letter to U.S. Senate and House health committee leaders in support of the Biosimilar Red Tape Elimination Act. The letter was signed by over three dozen leading advocacy groups representing health care, patients, consumers, employers, taxpayers, and policy think tanks.

  3. Marketing Approval For New Specification Of Ustekinumab Biosimilar ― USTEKINUMAB BS 90 mg Syringe For S.C. Injection 「F」 1/20/2026

    Fuji Pharma Co., Ltd. ("Fuji") has announced that it has received marketing approval for a new specification of USTEKINUMAB biosimilar.

  4. Professor Sarfaraz Niazi's Scientific Framework Adopted As FDA Modernizes Clinical Trial Evaluation Through Bayesian Methods 1/20/2026

    The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing Bayesian approaches that align with the long-standing scientific framework developed and advanced by Professor Sarfaraz K. Niazi, PhD, for evaluating drug and biosimilar efficacy without redundant clinical studies.

  5. Hikma Announces Launch Of Enoby (denosumab- qbde) And Xtrenbo (denosumab- qbde) Referencing Prolia And Xgeva Respectively 1/19/2026

    Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (Hikma) today announced the launch of Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), biosimilar products referencing Prolia and Xgeva respectively.

  6. Sandoz Confirms European Commission Approval Of Ondibta (insulin glargine), Strengthening Overall Biosimilars Leadership And Position In Diabetes 1/14/2026

    Sandoz the global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ondibta (insulin glargine), a solution for injection in a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals.

  7. Henlius' Fifth U.S. Filing Product Bevacizumab Biosimilar HLX04 Receives FDA BLA Acceptance 1/13/2026

    Shanghai Henlius Biotech, Inc. announced that the Biologics License Application (BLA) for HLX04, the Company’s independently developed bevacizumab biosimilar (a recombinant anti-VEGF humanized monoclonal antibody), has been formally accepted for review by the U.S. Food and Drug Administration (FDA). 

  8. Bio Usawa Receives Ghana FDA Approval For BioUcenta™ 1/13/2026

    Bio Usawa Biotechnology Ltd. (Bio Usawa, Inc.) today announced that the Ghana Food and Drugs Authority (Ghana FDA) has approved BioUcenta™, a biosimilar to Lucentis® (ranibizumab), for the treatment of diabetic macular edema, age-related macular degeneration, and diabetic retinopathy.

  9. Celltrion Presents Innovative Drug Pipeline And U.S. Manufacturing And R&D Expansion Strategy At The 44th Annual J.P. Morgan Healthcare Conference 1/13/2026

    Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

  10. Sandoz CEO, Speaking At 44th Annual J.P. Morgan Healthcare Conference, Will Outline Plans To Capitalize On Unprecedented 'Golden Decade' Of Affordable Medicines Opportunity 1/12/2026

    Sandoz, the global leader in affordable medicines, will today outline its plans to capitalize on the unprecedented market opportunity of the coming ‘golden decade’, in a presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, at 18:45 CET (9:45 PST).