Biosimilar Development News

  1. Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama 1/21/2025

    Formycon AG and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama.

  2. Sandoz To Confirm Strategic Roadmap And Highlight Pipeline Catalysts At 43rd Annual J.P. Morgan Healthcare Conference 1/14/2025

    Sandoz, the global leader in generic and biosimilar medicines, will confirm its strategic roadmap and highlight pipeline catalysts in a presentation today at the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13 to 16 in San Francisco.

  3. Henlius Broadens Access To Multiple Biologics In Emerging Markets 1/13/2025

    Shanghai Henlius Biotech, Inc. today announced it has entered into product license and supply agreement with Abbott, granting it exclusive or semi-exclusive licenses for the commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets in Asia, Latin America and the Caribbean, as well as Middle East and Africa.

  4. Teva Announces Collaboration To Commercialize Formycon's Biosimilar Candidate To Eylea® (aflibercept) In Major Parts Of Europe And In Israel 1/13/2025

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea® (aflibercept) in Europe, excluding Italy, and in Israel.

  5. Samsung Bioepis And Teva Enter Into A Strategic Partnership For Commercialization Of EPYSQLI® (eculizumab-aagh) In The United States 1/10/2025

    Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced today that the companies have entered into a license, development and commercialization agreement for EPYSQLI® (eculizumab-aagh), Samsung Bioepis’ biosimilar to Soliris®i (eculizumab) in the United States (U.S.).

  6. Fresenius Kabi Canada Has Received A Health Canada Notice Of Compliance (NOC) For Otulfi™* An Ustekinumab Biosimilar 1/9/2025

    Fresenius Kabi Canada proudly announces the recent Health Canada Notice of Compliance (NOC) for OtulfiTM, an ustekinumab biosimilar indicated for Crohn's disease, ulcerative colitis, plaque psoriasis and active psoriatic arthritis in adult patients.

  7. Expanding Horizons: Xentria Achieves Milestone Success With Biosimilar Development 1/8/2025

    Xentria, Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet medical needs, today announced operational expansion of multiple clinical trials in 2025, including global operational and site engagement in 11 countries across 3 regions.

  8. Formycon And Fresenius Kabi Canada Receive Health Canada's Approval For FYB202/Otulfi (ustekinumab), A Biosimilar To Stelara 1/8/2025

    Formycon AG and its commercialization partner Fresenius Kabi announce that Health Canada has issued a “Notice of Compliance” (NOC) for FYB202/Otulfi (ustekinumab), a biosimilar to Stelara.

  9. GlycoNex Announces Licensing Agreement For SPD8 Biosimilar 1/6/2025

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced a licensing agreement for its denosumab biosimilar, SPD8. This marks GlycoNex's strategic progress and a significant milestone in its global expansion strategy.

  10. Xbrane Files BLA For Ranibizumab Biosimilar Candidate To FDA 12/31/2024

    Xbrane Biopharma AB (publ) ("Xbrane" or the "Company") has submitted a BLA (Biologics License Application) for its biosimilar candidate for LUCENTIS (ranibizumab) to the FDA (US Food and Drug Administration).