Biosimilar Development News

  1. AscellaHealth Service And Infrastructure Enhancements Support Specialty Drug Manufacturers To Protect Market Share Across Brand, Biosimilar And Generic Launches 7/23/2025

    AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, announces service and infrastructure enhancements designed to help specialty and rare disease drug manufacturers respond to accelerating market disruption across the pharmaceutical landscape.

  2. GlycoNex To Participate In BIO Asia-Taiwan 2025 7/21/2025

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced its participation in the 2025 BIO Asia-Taiwan International Conference & Exhibition. The event will take place from July 23-27, 2025, at the Nangang Exhibition Center, Taipei.

  3. Samsung Bioepis Enters Into A Partnership With Harrow For Commercialization Of Ophthalmology Biosimilars Portfolio In The United States 7/17/2025

    Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States.

  4. Bio-Thera Solutions Announces FDA Accepts Biologics License Application For BAT2506, A Proposed Biosimilar To Simponi® 7/16/2025

    io-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab).

  5. Biocon Biologics Expands Diabetes Portfolio With FDA Approval Of Kirsty™, The First And Only Interchangeable Rapid-Acting Insulin Aspart In The United States 7/15/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable* biosimilar to NovoLog® (Insulin Aspart). KIRSTY is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

  6. Lupin And Zentiva Sign License And Supply Agreement For Commercializing Certolizumab 7/9/2025

    Global Pharma major Lupin Limited (Lupin) and Zentiva Group (Zentiva), a pan-European pharmaceutical company, have entered into a license and supply agreement for commercialization of Lupin’s biosimilar Certolizumab Pegol, across multiple markets globally.

  7. Zentiva And Lupin Sign License And Supply Agreement For TNF Alpha Inhibitor Biosimilar Medicine 7/9/2025

    Zentiva Group and global pharmaceutical company Lupin Limited, have entered into a license and supply agreement for commercialization of Lupin's biosimilar, TNF alpha inhibitor medicine, across multiple markets globally.

  8. Celltrion USA Announces U.S. Launch Of Denosumab Biosimilars, STOBOCLO® And OSENVELT® (denosumab-bmwo) 7/7/2025

    Celltrion USA today announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively, are commercially available in the United States.

  9. Advancing Bone Health: European Commission Approves Biocon Biologics' Denosumab Biosimilars 7/3/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab.

  10. Sunshine Biopharma Launches NIOPEG(R) Into $10B Biologics Market 7/2/2025

    Sunshine Biopharma Inc. (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched NIOPEG, the Company's first Biosimilar drug on the market.