Biosimilar Development News

  1. Alvotech Announces Changes In Global Business Development And Commercial Operations Team 10/22/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to its global business development and commercial operations team.

  2. Formycon's FYB201/Ranivisio Sets Innovative Standard As Europe's First Ranibizumab Biosimilar Available In Pre-Filled Syringe 10/21/2025

    Formycon AG (“Formycon”), Bioeq AG (“Bioeq”) and Teva Pharmaceutical Industries Ltd. (“Teva”) jointly announce the European launch of FYB201/Ranivisio as the first Lucentis3 biosimilar available in an EMA-approved innovative pre-filled syringe (“PFS”) presentation.

  3. Polpharma Biologics Announces Commercial Launch Of Europe's First Pre-Filled Syringe Presentation Of A Ranibizumab Biosimilar 10/21/2025

    Polpharma Biologics today announced Ranivisio PFS (ranibizumab biosimilar pre-filled syringe), is now commercially available in France.

  4. BIOCHINA2026 – Fusion Forward: Uniting The Global Biopharma Community In Suzhou 10/20/2025
  5. Teva And Prestige Biopharma Enter License Agreement For Tuznue® Commercialization In Europe 10/20/2025

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) entered into a license agreement with Prestige Biopharma, for the commercialization of Tuznue® (trastuzumab), a biosimilar to Herceptin®, across a majority of European markets.

  6. Bio Usawa Announces Approval Of BioUcenta™ By The Rwandan FDA 10/20/2025

    The Rwanda Food and Drugs Authority has granted market approval for Bio Usawa Biotechnology Ltd.’s (Bio Usawa) BioUcenta™, a biosimilar of Lucentis® (ranibizumab) for the treatment of diabetic macular edema, age-related macular degeneration and diabetic retinopathy.

  7. FDA Approves Expanded Pediatric Indications For YUFLYMA® (adalimumab-aaty) And Unbranded adalimumab-aaty In The United States 10/17/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA® (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.[1],[2]

  8. Biocon Biologics And Civica Expand Partnership And Launch Private-Label Insulin Glargine To Broaden U.S. Diabetes Treatment Options 10/16/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced expansion of its strategic collaboration with Civica, Inc. (Civica) to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins.

  9. Actor Pharmaceuticals And Megalabs Become Partners For The Commercialization Of Formycon's Eylea Biosimilar FYB203 (aflibercept) For Australia And Latin America 10/16/2025

    Formycon AG (“Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. (“Actor”) for the commercialization of FYB203 in Australia.

  10. Waltz Health And Serve You Rx Delivering Millions In Specialty Pharmacy Savings To Health Plans, Employers And Patients 10/14/2025

    Waltz Health, an EVERSANA company, today announced that its partnership with Serve You Rx is generating substantial savings through the use of Waltz Connect, Waltz Health's AI-powered specialty medication platform.