Biosimilar Development News

  1. Biocon Biologics Receives Health Canada Approval For Yesafili™ (aflibercept); First Global Launch Scheduled For July 2025 6/27/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Yesafili™ (aflibercept), a biosimilar to Eylea® (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL on June 26, 2025.

  2. Kashiv BioSciences Announces Positive Topline Results From Confirmatory Efficacy Study Of ADL-018, Biosimilar Candidate To XOLAIR (omalizumab) 6/25/2025

    Kashiv BioSciences, LLC today announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR (omalizumab).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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®.

  9. 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.

  10. 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.