Biosimilar Development News

  1. Henlius Accelerates The New Landscape Of Breast Cancer Treatment As HANQUYOU Marks Six Years Since Its Approval 8/11/2026

    In August 2026, Henlius' independently developed HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) marks the sixth anniversary of its approval in China.

  2. Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Pre-Filled Syringe Across Europe 8/10/2026

    Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ 40 mg/mL solution in pre-filled syringe (PFS), a biosimilar referencing Eylea1 (aflibercept), across Europe, starting today.

  3. Amneal Completes Acquisition Of Kashiv BioSciences, Creating A Global Biosimilar Leader 8/10/2026

    Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the completion of its acquisition of Kashiv BioSciences, LLC (“Kashiv”), creating a fully integrated global biosimilars leader with end-to-end capabilities across research, development, manufacturing and commercialization.

  4. Second PIC/S GMP Certification | Mabwell Passes Brazilian GMP Inspection For Its Denosumab Injections 8/9/2026

    Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announces that its wholly-owned subsidiary T-mab has successfully passed Brazilian Health Regulatory Agency's ("ANVISA") GMP on-site inspection for its denosumab biosimilars, 9MW0311 (Prolia® biosimilar) and 9MW0321 (Xgeva® biosimilar).

  5. Kyungdong Pharmaceutical And Asimov Announce Completion Of Cell Line Development Campaign For Biosimilar Antibody 8/9/2026

    Kyungdong Pharmaceutical announced that it has successfully completed a cell line development campaign for a biosimilar antibody candidate, in collaboration with Asimov, the company building an AI-native synthetic biology platform to advance therapeutic development.

  6. Biocon Announces U.S. Commercial Launch Of Yesafili, A Biosimilar To Regeneron's Eylea 2 mg 8/3/2026

    Biocon Limited, an innovation‑led global biopharmaceutical company, today announced the commercial launch of Yesafili (aflibercept-jbvf) in the United States.

  7. Fresenius Announces FDA Approval Of Rituximab Biosimilar For The U.S. Market 8/3/2026

    Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL), a biosimilar to Rituxan* (rituximab).1

  8. Polpharma Biologics Announces FDA And EMA Acceptance For Review Of PB016 Vedolizumab Biosimilar Candidate 7/31/2026

    Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

  9. Meitheal Pharmaceuticals Announces FDA Approval Of Garzulys (insulin aspart-fsan) Injection 7/30/2026

    Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys (insulin aspart-fsan) injection, a biosimilar to NovoLog (insulin aspart).

  10. HSCA Applauds House Energy And Commerce Commitee And Senate HELP Commitee For Advancing Bipartisan Biosimilars Legislation That Will Help Increase Access To Safe Medications 7/29/2026

    The Healthcare Supply Chain Association (HSCA) and its traditional healthcare group purchasing organization (GPO) members commend the U.S. House Committee on Energy and Commerce for unanimously advancing two bipartisan bills that would expand patient access to lower-cost biosimilars: the Expedited Access to Biosimilars Act (H.R. 9661), led by Reps.