Biosimilar Development News

  1. The Biosimilar Council Applauds Bipartisan Senate Legislation To Eliminate The Arbitrary Distinction Between Interchangeable Biologics And Biosimilars 6/5/2025

    The Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, today applauded the bipartisan introduction of the Biosimilar Red Tape Elimination Act in the United States Senate. 

  2. BioDlink Strengthens Global Compliance With Argentina GMP Certification 6/5/2025

    BioDlink has been granted GMP certification by National Administration of Drugs, Food and Medical Technology (ANMAT) of Argentina. This achievement adds to BioDlink's expanding portfolio of international GMP approvals, following recent certifications in Brazil, Indonesia, Egypt, and Colombia.

  3. Lucentis Biosimilar FYB201/Ranivisio (ranibizumab) Approved In Brazil 6/5/2025

    Formycon AG today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio1, a biosimilar to Lucentis2 (ranibizumab). Product launch by the Brazilian biopharma specialist Biomm is expected in Q4 2025, marking the beginning of a phased market rollout of FYB201/Raniviso across Latin America.

  4. Alvotech And Dr. Reddy's Enter Into Collaboration To Co-Develop Biosimilar Candidate To Keytruda® (pembrolizumab) 6/5/2025

    Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories Ltd., (along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that the companies have entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda (pembrolizumab) for global markets. Keytruda (pembrolizumab) is indicated for the treatment of numerous cancer types.

  5. Serve You Rx Adds Two New Biosimilars To Its Formulary, Delivering Up To 96% Cost Savings 6/5/2025

    Serve You Rx announced today that its Biosimilar Advantage Formulary now includes two newly approved biosimilars to Stelara (ustekinumab): Otulfi (ustekinumab-aauz) and Yesintek (ustekinumab-face).

  6. Alvotech Completes Acquisition Of Xbrane R&D Organization And Biosimilar Candidate To Cimzia 6/4/2025

    Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has completed its transaction with Xbrane Biopharma AB (“Xbrane”), with the acqusition of the R&D organization of Xbrane in Sweden and biosimilar candidate to Cimzia (certolizumab pegol). All regulatory conditions have been fulfilled.

  7. Generic And Biosimilar Patent Settlements Save $423B 6/3/2025

    The Association for Accessible Medicines and its Biosimilars Council today released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent settlements in expediting patient access to lower-cost medicine. 

  8. Sandoz Launches First And Only Interchangeable Denosumab Biosimilars In US, Providing New Affordable Treatment Options For Over 10 Million Patients[1] 6/2/2025

    Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the US starting today. 

  9. Alvotech And Advanz Pharma Extend Strategic Partnership To Commercialize Three Additional Biosimilars In Europe 5/28/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates.

  10. Bio-Thera Solutions And Hikma Pharmaceuticals Announce FDA Approval Of STARJEMZA® (ustekinumab-hmny) Injection, A Biosimilar Referencing STELARA® (ustekinumab) Injection 5/27/2025

    Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera's third FDA approved product.