Biosimilar Development News

  1. BioDlink's Bevacizumab Approved For Market Launch In Nigeria, Accelerating Global Expansion 6/16/2025

    BioDlink announced that its self-developed Bevacizumab Injection (Pusintin®) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria.

  2. Celltrion Announces U.S. FDA Approval Of Additional Presentation Of STEQEYMA® (ustekinumab-stba), Expanding Dosing Options For Pediatric Patients 6/15/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection.

  3. Nanoform Starts Pivotal Human Bioequivalence Studies Of Nanoenzalutamide 6/12/2025

    Nanoform Finland Plc, the medicine performance-enhancing company, today announced that it had started pivotal relative bioequivalence studies of Nanoenzalutamide, the nanocrystalline-enabled enzalutamide tablet formulation, a potential alternative to the amorphous solid dispersion (ASD) used in XTANDI® (enzalutamide) [1], the number one prescribed androgen receptor inhibitor [2] approved to treat prostate cancer.

  4. OneSource And Xbrane Biopharma Announce Biosimilars Manufacturing Partnership For The Global Markets 6/11/2025

    OneSource Specialty Pharma Limited, a multi-modality specialty pharma pure-play CDMO, and Xbrane Biopharma AB, a Sweden-headquartered biotechnology company, today announced a partnership focused on the commercial manufacturing of Xbrane’s biosimilar portfolio.

  5. 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. 

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.