Biosimilar Development News

  1. Fresenius Receives Positive CHMP Opinion For Their Denosumab Biosimilar Candidates 5/27/2025

    Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of its biosimilar candidates to (1) Prolia (denosumab) and (2) Xgeva (denosumab).

  2. Lupin And Steincares Enter Into License And Supply Agreement For Ranibizumab In Latin America 5/26/2025

    Global Pharma major Lupin Limited (Lupin) today announced that it has entered into a license and supply agreement with SteinCares, a leading specialty healthcare company in Latin America, for commercialization of Lupin’s biosimilar ranibizumab across Latin America excluding Mexico and Argentina.

  3. Xbrane Biopharma AB (publ) ('Xbrane' Or 'The Company') Updates On US FDA BLA (Biologics License Application) For Its Investigational Biosimilar Candidate To LUCENTIS (ranibizumab) 5/23/2025

    Xbrane re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to the FDA (US Food and Drug Administration) in December 2024.

  4. Biosimilars Forum Submits Comments To Accelerate Safe And Effective Biosimilar Development By Modernizing The FDA And Eliminating Bureaucratic Inefficiencies 5/22/2025

    The Biosimilars Forum submitted comments to OMB Director Vought on commonsense, necessary steps to optimize the FDA and eliminate inefficiencies in its biosimilars approval program.

  5. IGBA Welcomes ICH New Topic For Harmonisation: Framework For Determining Utility Of Comparative Efficacy Studies In Biosimilar Development Programs 5/21/2025

    The International Generic and Biosimilar medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs."

  6. Fresenius Kabi To Announce The Commercial Launch Of Tyenne®*, The First And Only Approved Tocilizumab Biosimilar In Canada 5/21/2025

    Fresenius Kabi Canada announces that its tocilizumab biosimilar Tyenne® referencing Actemra®** (tocilizumab) is now commercially available in Canada.

  7. Sandoz Launches Pyzchiva Autoinjector, First Commercially Available In Europe For Ustekinumab Biosimilars 5/21/2025

    Sandoz, the global leader in generic and biosimilar medicines, today announced the European launch of its Pyzchiva* (ustekinumab) autoinjector.[1-2]

  8. Celltrion's YUFLYMA® (adalimumab-aaty) Receives FDA Interchangeability Designation For All Its Approved Dosage Forms And Strengths 5/21/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations.

  9. First Subject Dosed For Phase 1/3 Clinical Trial Of Henlius' Proposed Ipilimumab Biosimilar 5/16/2025

    Shanghai Henlius Biotech, Inc. announced that the first subject was dosed for a phase 1/3 clinical trial of the company's independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in China.

  10. The Biosimilars Forum Submits Comments Highlighting Biosimilars As Safe And Effective Lower-Cost Medicines For Americans That Need Them 5/13/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the submission of the Biosimilars Forum’s comments to the Department of Commerce regarding their ongoing Section 232 investigation into the national security impact of imports of pharmaceuticals and pharmaceutical ingredients.