Biosimilar Development News

31. CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes For Tyenne (tocilizumab-aazg) 4/9/2026

    Fresenius Kabi, a part of Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the Centers for Medicare & Medicaid Services has issued indication-specific Healthcare Common Procedure Coding System (HCPCS) codes for Tyenne (tocilizumab-aazg) for the treatment of COVID-19.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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).

37. 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.

38. 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.

39. 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.

40. 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.