Biosimilar Development News

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Medimpact Expands Access To Two Biosimilars For Stelara 2/26/2025

    MedImpact Healthcare Systems, the nation’s largest independent provider of health solutions, technology, and pharmacy benefit management services, announced that it is expanding access to two biosimilar alternatives to Stelara (ustekinumab), Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce).

  9. Kashiv BioSciences, LLC Obtains Marketing Authorization For Pegfilgrastim Injection From Health Canada 2/25/2025

    Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling its commercial launch in this market.

  10. Sandoz Launches Biosimilar Pyzchiva® (ustekinumab-ttwe) In The US, Offering New Treatment For Around 12 Million Patients[1-4] 2/24/2025

    Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab-ttwe) in the US. From today, the medicine is commercially available to patients across the US.