Biosimilar Development News

  1. Xbrane Submits Ranibizumab Biosimilar Candidate To FDA 4/30/2026

    Xbrane Biopharma AB has submitted an application for approval (BLA) to the U.S. Food and Drug Administration for its biosimilar candidate to LUCENTIS (ranibizumab).

  2. EirGenix Advances Into CPHI Japan, Capitalizing On Market Trends To Deepen Its Strategic Footprint In Japan 4/29/2026

    As the global biopharmaceutical industry undergoes rapid restructuring, two powerful forces—policy evolution and supply chain transformation—are reshaping Japan's landscape.

  3. European Commission (EC) Approves Henlius And Organon's POHERDY (pertuzumab), The First Approved Biosimilar To PERJETA (pertuzumab) In Europe 4/29/2026

    Shanghai Henlius Biotech, Inc., and Organon today announced the European Commission (EC) has granted marketing authorization for POHERDY (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1

  4. The Biosimilars Forum Commends Governor Spanberger For Supporting Lower-Cost Medicines In Virginia 4/23/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement in response to Governor Spanberger’s rejection of the Virginia legislature’s Maximum Fair Price (MFP) proposal.

  5. Mabwell Announces Acceptance Of Supplemental Biologics License Application By NMPA For MAIWEIJIAN (Denosumab) 4/21/2026

    Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain, announced that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

  6. Announcement Of Partnership Agreement For The Biosimilar Of Follitropin Alfa 4/21/2026

    Mochida Pharmaceutical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo; President: Naoyuki Mochida; hereinafter “Mochida”) hereby announces that it has entered into an agreement with Qilu Pharmaceutical Co., Ltd. (Head Office: Jinan, Shandong Province, China; General Manager: ZHANG Hanchang; hereinafter “Qilu”) regarding the development and commercialization in Japan of Qilu’s biosimilar of follitropin alfa (genetical recombination) (hereinafter “the Product”).

  7. Biocon Receives Health Canada Approval Of Bosaya (Denosumab) And Vevzuo (Denosumab), Biosimilars To Prolia And Xgeva 4/21/2026

    Biocon Limited, an innovation‑led global biopharmaceutical company, is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Bosaya (denosumab), a biosimilar to Prolia, and Vezuo (denosumab), a biosimilar to Xgeva, on April 3, 2026.

  8. JAMP Pharma Group Strengthens Its Immunology Biosimilars Portfolio With PrUpgolyv™, A Golimumab Biosimilar That Has Receive Its Notice Of Compliance By Health Canada 4/20/2026

    With the authorization of PrUpgolyv™ (golimumab injection) by Health Canada, JAMP Pharma Group continues to build momentum in its immunology-focused biosimilars pipeline, delivering innovative, cost-effective treatment options for patients with inflammatory autoimmune diseases.

  9. Accord BioPharma's IMULDOSA® (ustekinumab-srlf) Now Preferred Under Cigna Healthcare Commercial Plans 4/20/2026

    Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology and immunology therapies, announced IMULDOSA® (ustekinumab-srlf) is now covered by Cigna Healthcare, effective April 15, 2026.

  10. Mabwell Passes On-Site GMP Inspection By Regulatory Authority Of PIC/S Member Country (Jordan) For The First Time 4/20/2026

    Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its wholly-owned subsidiary, T-mab, has successfully passed the on-site GMP inspection conducted by the Jordan Food and Drug Administration (JFDA).