Biosimilar Development News

  1. Biocon Biologics And Civica Expand Partnership And Launch Private-Label Insulin Glargine To Broaden U.S. Diabetes Treatment Options 10/16/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced expansion of its strategic collaboration with Civica, Inc. (Civica) to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins.

  2. Actor Pharmaceuticals And Megalabs Become Partners For The Commercialization Of Formycon's Eylea Biosimilar FYB203 (aflibercept) For Australia And Latin America 10/16/2025

    Formycon AG (“Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. (“Actor”) for the commercialization of FYB203 in Australia.

  3. Waltz Health And Serve You Rx Delivering Millions In Specialty Pharmacy Savings To Health Plans, Employers And Patients 10/14/2025

    Waltz Health, an EVERSANA company, today announced that its partnership with Serve You Rx is generating substantial savings through the use of Waltz Connect, Waltz Health's AI-powered specialty medication platform.

  4. 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.

  5. 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]

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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”).