Biosimilar Development News

  1. Formycon Secures License Date For Aflibercept 2 mg Biosimilar FYB203 In Europe And Further Territories Following Settlement With Regeneron And Bayer 3/19/2026

    Formycon AG (“Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea1 2 mg biosimilars AHZANTIVE2 and Baiama3.

  2. Samsung Bioepis Enters Into Partnership Agreement With Sandoz For Up To Five Next-Generation Biosimilar Candidates 3/18/2026

    Samsung Bioepis Co., Ltd. announced today that the company has entered into a global license, development and commercialization agreement (DCA) with Sandoz for up to five biosimilar candidates under development by Samsung Bioepis, including SB36, a biosimilar candidate referencing Entyvio1 (vedolizumab).

  3. Biopharma SHAKTI Scheme 3/17/2026

    With a view to strengthen the domestic biopharmaceutical sector and enhance global competitiveness in biologics and biosimilars, the Government has announced the Biopharma SHAKTI scheme with an outlay of ₹10,000 crore over five years with an objective to build a globally competitive domestic ecosystem for biologics and biosimilars to support affordable healthcare in India and enable India to emerge as a global biopharma manufacturing and innovation hub.

  4. 3PBIOVIAN And INC Partner To Expand Access To Oncology Treatments In Colombia Through Biosimilar Development 3/13/2026

    3PBIOVIAN, a leading Contract Development and Manufacturing Organization (CDMO), and the National Cancer Institute (Instituto Nacional de Cancerología) in Colombia (INC) has signed a contract to carry out the development of a biosimilar monoclonal antibody (mAb) for an oncology indication, marking the first biosimilar mAb to be developed specifically for expanding access to oncology treatments in Colombia.

  5. Celltrion Set To Benefit From Global Biosimilar Regulatory Streamlining, Driving Economies Of Scale From Development To Manufacturing And Direct Sales 3/13/2026

    Celltrion announced today that it will immediately incorporate newly announced global regulatory updates aimed at streamlining biosimilar development into its ongoing pipeline programs, with the goal of significantly reducing development costs and timelines.

  6. Celltrion Launches Remsima IV Liquid Formulation In Europe, Securing New Competitiveness To Lead The Global infliximab Market 3/11/2026

    Celltrion today announced the European launch of the liquid formulation of Remsima (infliximab), strengthening its leadership in the infliximab market.

  7. AAM And Biosimilars Council Laud FDA Plan To Streamline Biosimilar Medicines Development And Lower Costs For Patients 3/10/2026

    The Association for Accessible Medicines and its Biosimilars Council today lauded FDA updated guidance to streamline and lower costs to develop biosimilar medicines.

  8. Gannet BioChem Files Type II Drug Master File For mPEG Propionaldehyde 20K To Support Pegfilgrastim Biosimilars 3/10/2026

    Gannet BioChem, a leading life sciences manufacturing company, today announced that it has filed a Type II Drug Master File under its Arab, AL facility (FEI 3006223361) for its PEG propionaldehyde 20K, to support the development and commercialization of pegfilgrastim biosimilars.

  9. FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised By Professor Niazi: Further Cutting Development Costs By Up to 50% 3/10/2026

    The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)1, a sweeping guidance that codifies multiple regulatory modernization proposals first advanced by Professor Sarfaraz K. Niazi, pharmaceutical scientist, Adjunct Professor at the University of Illinois Chicago (College of Pharmacy), and regulatory advisor to the FDA, EMA, and MHRA.

  10. mAbxience Selects Genedata Bioprocess To Automate End-To-End CDMO Workflows 3/10/2026

    Genedata, a Danaher company and the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced that mAbxience has selected the Genedata Bioprocess® enterprise platform to structure and harmonize all bioprocess development data across its operations.