Biosimilar Development News

31. Samsung Epis Holdings Delivers Business Updates At The 44^th J.P. Morgan Healthcare Conference 1/14/2026

    Samsung Epis Holdings today shared corporate progress and updates at the 44^th J.P. Morgan Healthcare Conference.

32. Sandoz Confirms European Commission Approval Of Ondibta (insulin glargine), Strengthening Overall Biosimilars Leadership And Position In Diabetes 1/14/2026

    Sandoz the global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ondibta (insulin glargine), a solution for injection in a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals.

33. Henlius' Fifth U.S. Filing Product Bevacizumab Biosimilar HLX04 Receives FDA BLA Acceptance 1/13/2026

    Shanghai Henlius Biotech, Inc. announced that the Biologics License Application (BLA) for HLX04, the Company’s independently developed bevacizumab biosimilar (a recombinant anti-VEGF humanized monoclonal antibody), has been formally accepted for review by the U.S. Food and Drug Administration (FDA). 

34. Bio Usawa Receives Ghana FDA Approval For BioUcenta™ 1/13/2026

    Bio Usawa Biotechnology Ltd. (Bio Usawa, Inc.) today announced that the Ghana Food and Drugs Authority (Ghana FDA) has approved BioUcenta™, a biosimilar to Lucentis® (ranibizumab), for the treatment of diabetic macular edema, age-related macular degeneration, and diabetic retinopathy.

35. Celltrion Presents Innovative Drug Pipeline And U.S. Manufacturing And R&D Expansion Strategy At The 44^th Annual J.P. Morgan Healthcare Conference 1/13/2026

    Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

36. Sandoz CEO, Speaking At 44^th Annual J.P. Morgan Healthcare Conference, Will Outline Plans To Capitalize On Unprecedented 'Golden Decade' Of Affordable Medicines Opportunity 1/12/2026

    Sandoz, the global leader in affordable medicines, will today outline its plans to capitalize on the unprecedented market opportunity of the coming ‘golden decade’, in a presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, at 18:45 CET (9:45 PST).

37. Boan's Denosumab (60mg) Approved For Market Launch In Bolivia 1/9/2026

    Boan Biotech announced that its self-developed Denosumab Injection 60mg (BA6101) has officially received approval for market from the Bolivian National Agency of Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED).

38. Biocon Biologics To Expand Biosimilar Oncology Portfolio, Outline Strategic Vision At The 2026 J.P. Morgan Healthcare Conference 1/6/2026

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., will introduce three new oncology biosimilars, further strengthening its comprehensive cancer portfolio.

39. Fresenius Kabi Introduces New Presentation Of Otulfi (ustekinumab-aauz), A Biosimilar To Stelara 1/6/2026

    Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced a new presentation of Otulfi (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

40. Accord BioPharma's HERCESSI™ (trastuzumab-strf) Gains Preferred Status On Express Scripts National Commercial Formularies 1/5/2026

    Accord BioPharma Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that Express Scripts, one of the nation's largest pharmacy benefit managers, has added HERCESSI™ (trastuzumab-strf) to preferred status on its largest commercial formularies, including National Preferred Formulary, effective January 1, 2026.