Biosimilar Development News

  1. Aurobindo arm CuraTeQ Reports Positive Phase 3 Results For Allergy Drug BP11 4/7/2026

    Aurobindo Pharma’s wholly owned subsidiary, CuraTeQ Biologics, has reported positive top-line results from the Phase 3 trial of its omalizumab biosimilar, BP11, indicating comparable efficacy and safety to the reference drug, Xolair.

  2. 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.

  3. 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.

  4. Thermo Fisher Scientific Launches Integrated Platform To Accelerate Biologics Development 4/1/2026

    Thermo Fisher Scientific Inc., the world leader in serving science, today announced a next-generation, integrated cell line development platform that enables biologics developers to accelerate time to clinic while maintaining regulatory confidence and commercial scalability.

  5. 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).

  6. 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.

  7. 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.

  8. 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. 

  9. Shreehas Tambe Appointed CEO & Managing Director Of Biocon Limited, Effective April 1, 2026 3/27/2026

    Biocon Limited today announced the appointment of Shreehas Tambe as its Chief Executive Officer & Managing Director, effective April 1, 2026, following approvals from the Nomination & Remuneration Committee and the Board of Directors.

  10. 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.