Biosimilar Development News

  1. Rezon Bio Appoints Dr. Ralf Otto As Chief Operating Officer To Support Next Phase Of Growth And Operational Expansion 6/3/2026

    Rezon Bio, a science-driven European biologics contract development and manufacturing organization (CDMO), today announced the appointment of Dr. Ralf Otto, as Chief Operating Officer (COO) effective June 1, 2026.

  2. Chime Biologics And Daewoong Pharmaceutical Enter Strategic Partnership To Advance Dupilumab Biosimilar Development And Commercialization In Global Markets 6/2/2026

    Chime Biologics, a global biologics CDMO dedicated to enabling partners’ success, and Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, today announced the signing of a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Dupixent.

  3. USP Publishes Product-Specific Emerging Biologics Standards For Public Comment 6/1/2026

    The U.S. Pharmacopeia (USP) today announced the publication of a set of product-specific biologics emerging standards, now available for public comment through the Emerging Standards Platform.

  4. Henlius' Pertuzumab Approved In China, Solidifying Breast Cancer Strategy As The First China-US-EU Approved Chinese Trastuzumab-Pertuzumab Combination 5/29/2026

    Henlius announced that the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY) has been approved by the National Medical Products Administration (NMPA).

  5. Boan Biotech Submits A Biologics License Application For Two Denosumab Biosimilars In The U.S. 5/29/2026

    Boan Biotech announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its two biosimilars: BA6101 (denosumab injection 60 mg) and BA1102 (denosumab injection 120 mg). This submission marks a milestone in the company’s efforts to accelerate the global expansion of its core products.

  6. Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Vial Across Europe, To Treat Ophthalmic Conditions 5/29/2026

    Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea1 (aflibercept), across Europe, starting today.

  7. A580 - Multiple Sclerosis Medication: The Italian Competition Authority Launches Investigation Into Biogen 5/27/2026

    Authority concerned that the Biogen group may have pursued a strategy designed to exclude and limit competition from Sandoz, a new entrant, in the market for drugs treating multiple sclerosis containing natalizumab.

  8. Globalisation 2.0 | First Patient Dosed In China For International Multi-Centre Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC 5/26/2026

    Shanghai Henlius Biotech, Inc. today announced that the first patient in China has been dosed in the international multi-centre Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM).

  9. Polpharma Biologics And Tuteur Sign Licensing Agreement For A Biosimilar For Autoimmune Diseases 5/22/2026

    Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, today announced the signing of a landmark licensing agreement with Argentina-based Tuteur.

  10. Mabwell Announces NMPA Approval Of Supplemental Application For Additional Indications Of MAIWEIJIAN (Denosumab Injection) 5/21/2026

    Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk of skeletal-related events (pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery)) .