Biosimilar Development News

  1. Apotex Strengthens Osteoporosis Care In Canada With Health Canada's Approval Of DENOZA™, A Denosumab Biosimilar 4/7/2026

    Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications.

  2. Biocon Announces U.S. Commercial Launch Of Bosaya And Aukelso, Denosumab Biosimilars 4/7/2026

    Biocon Limited, an innovation‑led global biopharmaceutical company, today announced the commercial launch of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States.

  3. Enhancing Treatment For Breast Cancer: China's First Subcutaneous Pertuzumab/Trastuzumab Combination HLX319 Approved For Clinical Trial 4/1/2026

    Shanghai Henlius Biotech, Inc. today announced that the Investigational New Drug (IND) application for HLX319, the company's self-developed, fixed-dose subcutaneous injection of pertuzumab and trastuzumab, has been approved by the China National Medical Products Administration (NMPA).

  4. Miller-Meeks Leads Bipartisan Bill To Lower Prescription Drug Costs For Seniors 3/31/2026

    Dr. Mariannette Miller-Meeks (IA-01), alongside Congresswoman Doris Matsui (D-CA) and Congressman Jake Auchincloss (D-MA) are leading bipartisan legislation to expand Medicare beneficiaries’ access to more affordable prescription drugs.

  5. Xbrane Provides An Update On The Timeline For Resubmission Of The Market Authorization Application In The United States 3/31/2026

    Xbrane Biopharma AB (publ) announces today that the company intends to resubmit its Biologics License Application (BLA) for the ranibizumab biosimilar to the U.S. Food and Drug Administration (FDA) during April/May 2026.

  6. STADA Strikes Deal With CuraTeQ For Neutropenia Biosimilars In Europe 3/30/2026

    STADA Arzneimittel AG has entered into a marketing and distribution agreement with CuraTeQ Biologics S.r.o, a subsidiary of Aurobindo Pharma Ltd focused on biosimilars, to bring to market two neutropenia biosimilars in Europe.

  7. Teva Gains Biosimilar Momentum With U.S. FDA Approval Of PONLIMSI™ (denosumab-adet) And Dual Filing Acceptance For Biosimilar Candidate To Xolair® (omalizumab) 3/30/2026

    Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. 

  8. Neion Bio Emerges From Stealth With Multi-Product Biosimilar Partnership Leveraging Its Cutting-Edge Genetic Engineering Platform 3/26/2026

    Neion Bio, a biotechnology company revolutionizing the production of biologic medicines, today announced its emergence from stealth and the signing of its first co-development and supply agreement with a major global pharmaceutical company.

  9. AEON Biopharma Announces FDA Feedback Following BPD Type 2a Meeting For The ABP-450 Biosimilar Program 3/25/2026

     AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced feedback from the U.S. Food and Drug Administration (“FDA” or the “Agency”) following a successful Biosimilar Biological Product Development (BPD) Type 2a meeting.

  10. Mabwell Established A Licensing And Commercialization Agreement Of Denosumab Biosimilars For Vietnamese Market 3/25/2026

    Mabwell, an innovative biopharmaceutical company with entire industry chain, announced that it has established a licensing and commercialization agreement with a strategic business partner (“the partner”) in Vietnam for its Denosumab biosimilar products MAILISHU (Prolia biosimilar) and MAIWEIJIAN (Xgeva biosimilar).