Biosimilar Development News

  1. Bio-Thera Solutions Receives Positive CHMP Opinion For USYMRO®(ustekinumab), A Biosimilar Referencing Stelara® 6/20/2025

    Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for USYMRO® (ustekinumab), a biosimilar monoclonal antibody referencing Stelara®.

  2. 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.

  3. 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.

  4. 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.

  5. Samsung Bioepis Presents Long-Term Safety Data Of EPYSQLI (Eculizumab) In PNH At The European Hematology Association (EHA) Congress 2025 6/12/2025

    Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) today presented the long-term safety data of EPYSQLI™ (eculizumab; SB12), a biosimilar to Soliris1, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15.

  6. 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.

  7. Samsung Bioepis Enters Into A Strategic Partnership With NIPRO For Commercialization Of Multiple Biosimilars In Japan 6/8/2025

    Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement with NIPRO Corporation (“NIPRO”) for multiple biosimilar candidates including SB17, ustekinumab biosimilar candidate, in Japan.

  8. 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. 

  9. 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.

  10. 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.