Biosimilar Development News

  1. Lannett Company, Lanexa Biologics And Sunshine Lake Pharma Announce FDA Approval Of LANGLARA An Interchangeable Biosimilar Of Lantus (insulin glargine) 5/4/2026

    Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved LANGLARA (insulin glargine-aldy), as a biosimilar to Lantus (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

  2. 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).

  3. 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.

  4. 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

  5. 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.

  6. Kashiv BioSciences Agrees To Be Acquired By Amneal Pharmaceuticals To Create A Fully Integrated Global Biosimilar Leader 4/22/2026

    Kashiv BioSciences, LLC (“Kashiv”), today announced that it has entered into a definitive agreement to be acquired by Amneal Pharmaceuticals, Inc. (“Amneal”).

  7. 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.

  8. 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”).

  9. 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.

  10. 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.