Biosimilar Development News

  1. Bio-Thera Solutions Announces Expansion Of Partnership With Intas Pharmaceuticals For BAT2506, A Proposed Biosimilar Referencing Simponi® (golimumab), Through Exclusive Commercialization And License Agreement In Canada 10/9/2025

    Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced an expansion of its partnership with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, through an exclusive commercialization and license agreement for Canada.

  2. Celltrion Receives U.S. FDA Approval For EYDENZELT® (aflibercept-boav), Biosimilar Referencing EYLEA® (aflibercept) 10/9/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).[1]

  3. Peek Healthcare Technologies, Inc. ('Peek') Launches Direct-To-Employer And Direct-To-Patient Pricing For IMULDOSA(R) (ustekinumab-srlf) (Stelara(R) Biosimilar) 10/8/2025

    Peek, a leading healthcare technology company, today announced the launch of PeekDirect pricing for IMULDOSA (ustekinumab-srlf), a biosimilar to Stelara (ustekinumab), delivering transparent and dramatically lower costs to employers and patients.

  4. The Biosimilars Forum Calls For State Policies That Support Lower-Cost Prescription Drugs Including Biosimilars For Patients That Need Them 10/7/2025

    Federal and state governments must support policies that lower prescription drug costs for Americans and support a sustainable and thriving biosimilars market.

  5. Hikma And Celltrion Strengthen Partnership To Expand Biosimilar Access In MENA 10/6/2025

    Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, and its long-standing partner Celltrion Inc., a global biopharmaceutical leader, have signed exclusive licensing agreements across the Middle East and North Africa (MENA) region.

  6. Kashiv Biosciences Announces Submission Of Biologics License Application To U.S. FDA And Acceptance Of Market Authorization Application By European Medicines Agency For ADL-018, A Proposed Biosimilar To XOLAIR (omalizumab) 10/6/2025

    Kashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR (omalizumab).

  7. Execution Of Agreements Regarding The Joint Development Of Biosimilars For Specified Products 10/6/2025

    Alfresa Holdings Corporation (head office: Chiyoda-ku, Tokyo; Representative Director & President: Ryuji Arakawa; hereinafter “Alfresa Holdings”); Kidswell Bio Corporation (head office: Chuo-ku, Tokyo; President & CEO: Shinya Kurebayashi; hereinafter “Kidswell”); and Chiome Bioscience Inc. (head office: Shibuya-ku, Tokyo; President & CEO: Masamichi Koike; hereinafter “Chiome”) have entered into agreements regarding the joint development of biosimilars*1 for specified products (hereinafter referred to as the “Agreement”).

  8. European Marketing Application For AVT23, A Proposed Biosimilar To Xolair® (omalizumab), Accepted By The European Medicines Agency 10/6/2025

    Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab).

  9. Formycon Secures U.S. License Date For Proposed Aflibercept Biosimilar FYB203 Following Settlement And License Agreement With Regeneron 10/2/2025

    Formycon AG, together with its license partner Klinge Biopharma GmbH (“Klinge”) and Valorum Biologics (“Valorum”), announces a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”), resolving all patent disputes related to its FDA-approved Eylea2 biosimilar for the U.S. market.

  10. Celltrion Launches AVTOZMA® (tocilizumab-anoh) Intravenous (IV) Formulation In The United States 10/2/2025

    Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States.