Biosimilar Development News

  1. Federal Budget 2026-27: Biosimilars Recognised As An Opportunity To Expand Patient Access 5/13/2026

    The 2026-27 Federal Budget marks a significant milestone in efforts to expand access to biologic medicines.

  2. IQVIA And Kexing Biopharm Expand Strategic Collaboration To Accelerate Global Biosimilar Development Using AI-Enabled Capabilities 5/13/2026

    IQVIA a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, is advancing its strategic collaboration with Kexing Biopharm to support a global, multi-product biosimilar development and commercialization program.

  3. Globalisation 2.0 | U.S. FDA Clearance Of IND For Cetuximab Biosimilar HLX05-N 5/10/2026

    On May 10, 2026, Shanghai Henlius Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for HLX05-N, Henlius' self-developed biosimilar of cetuximab (The recombinant anti-EGFR human/murine chimeric monoclonal antibody), for the treatment of metastatic colorectal cancer (mCRC).

  4. Xbrane And Its Partner Intas Agree On Revised Financing Arrangement For Xbrane's Xdivane Development Activities 5/5/2026

    Xbrane Biopharma AB (publ) (“Xbrane” or the “Company”) is co-developing Xdivane (Opdivo biosimilar candidate) together with its partner Intas Pharmaceuticals Ltd. (“Intas”).

  5. CVS Caremark Expands Biosimilar Adoption Through Formulary Updates To Improve Affordability And Access 5/5/2026

    CVS Health (NYSE: CVS) today announced updates to its most common commercial template formularies that will expand the use of lower-cost biosimilars across multiple therapeutic categories, including changes effective July 1, 2026, that will prefer interchangeable biosimilars over select reference brands.

  6. 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.

  7. 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).

  8. 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.

  9. 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

  10. 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.