Biosimilar Development News

  1. STEQEYMA® (ustekinumab-stba), A Biosimilar To STELARA® (ustekinumab), Now Available In The United States 3/12/2025

    Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024.

  2. Celltrion's Infliximab, The First Monoclonal Antibody Biosimilar, Is Now Remdantry™ In Canada 3/11/2025

    Celltrion, Inc., a leading global biopharmaceutical company, announced today that its infliximab biosimilar will be marketed in Canada under the new brand name Remdantry starting April 1, 2025, following approval of the product name change by Health Canada.

  3. U.S. FDA Approves Celltrion's OMLYCLO® (omalizumab-igec) As The First And Only Biosimilar With Interchangeability Designation Referencing XOLAIR® 3/9/2025

    Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).

  4. Xevant Introduces The All-New Biosimilar Dashboard, A Real-Time Analytics Tool To Accelerate Biosimilar Adoption And Reduce Unnecessary Biologic Drug Spend 3/7/2025

    Xevant, a leader in pharmacy benefits automation, today announces the launch of its all-new Biosimilar Dashboard, a real-time analytics tool designed to streamline biosimilar adoption and reduce unnecessary spending on biologic drugs.

  5. Biocon Biologics Announces Positive Results From Phase 3 Study Of Yesintek™ Biosimilar To Ustekinumab For Chronic Plaque Psoriasis 3/7/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced the successful results of a pivotal Phase 3, randomized, double-blind, parallel group, multicenter study comparing Yesintek™ (Biocon Biologics' biosimilar to Ustekinumab, called YESINTEK) with reference product Stelara (Ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis (PsO).

  6. Fresenius Continues Growth Of Biosimilars Portfolio With The U.S. Availability Of Otulfi (ustekinumab-aauz) 3/3/2025

    Fresenius Kabi, an operating company of Fresenius, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the ustekinumab biosimilar Otulfi (ustekinumab-aauz) developed by Formycon AG, is now available in the United States.

  7. Biosimilars Canada Announces Board Chair And Vice-Chair For 2025 3/3/2025

    Biosimilars Canada is pleased to announce the unanimous election of Mike Casia, President and Managing Director of Organon Canada, as Chair of Biosimilars Canada for 2025.

  8. Celltrion Receives U.S. FDA Approval For STOBOCLO® (denosumab-bmwo) And OSENVELT® (denosumab-bmwo) Biosimilars Referencing PROLIA® And XGEVA® 3/3/2025

    Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products.

  9. Amneal's BLA Submissions For Two Denosumab Biosimilars Accepted For Review By U.S. FDA 3/3/2025

    Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia and XGEVA.

  10. SmithRx Introduces Stelara Biosimilars To Its Autoimmune Program, Helping Clients Save A Projected $14.5M In Prescription Drug Costs 2/28/2025

    SmithRx, a transparent, 100% pass-through modern pharmacy benefits manager (PBM), today announced a major expansion to its Connect 360 Autoimmune Program, including the introduction of Stelara biosimilars to its offering, new low-cost Humira and Stelara biosimilars for pediatric members, and a partnership with Costco Specialty Pharmacy alongside its long-standing relationship with Mark Cuban Cost Plus Drugs.