Biosimilar Development News

  1. Bio-Thera Solutions And SteinCares Expand Partnership To Commercialize Biosimilars For Treatment Of Inflammatory Diseases Across Latin America 6/25/2025

    Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and SteinCares, a leading specialty healthcare company in Latin America, today announced the signing of a new agreement to commercialize a proposed biosimilar of dupilumab across Latin America.

  2. Amneal Highlights Positive Topline Results From Confirmatory Clinical Study Of Biosimilar Candidate To XOLAIR® (omalizumab), Developed By Kashiv BioSciences 6/25/2025

    Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC.

  3. Positive Top Line Results From Confirmatory Efficacy Study For Proposed Biosimilar To Xolair® (omalizumab) 6/25/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

  4. Biocon Biologics Collaborates With National Cancer Society Malaysia 6/24/2025

    Biocon Biologics Limited, a fully integrated global biosimilars company, has partnered with the National Cancer Society of Malaysia (NCSM), a prominent not-for-profit cancer organization, to launch a Patient Assistance Program (PAP) in Malaysia aimed at improving access to affordable, high-quality biosimilars for underserved cancer patients in Malaysia.

  5. European Medicines Agency Recommends Market Approval Of AVT06, Alvotech's Proposed Biosimilar To Eylea® (aflibercept) 6/23/2025

    lvotech (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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg).

  6. 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®.

  7. 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.

  8. 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.

  9. 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.

  10. 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.