Biosimilar Development News

  1. FDA Approves Expanded Indication For AVTOZMA® (tocilizumab-anoh) intravenous (IV) Formulation In Cytokine Release Syndrome (CRS) 8/6/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older. 

  2. Polpharma Biologics And Fresenius Kabi Sign Licensing Agreement For Proposed Vedolizumab Biosimilar PB016 8/5/2025

    Polpharma Biologics S.A. (“Polpharma Biologics”) announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn’s disease.

  3. Kashiv BioSciences And MS Pharma Enter Into MENA License And Supply Agreement For ADL-018, Biosimilar Candidate To XOLAIR (bOmalizumab) 8/5/2025

    Kashiv BioSciences, LLC and MS Pharma today announced that the companies have entered into a license and supply agreement for ADL-018, Kashiv BioSciences’ biosimilar candidate to XOLAIR (bOmalizumab) in the Middle East and North Africa (MENA) region. IQVIA reported global sales of ~$4.5B and ~$60M in MENA in 2024.

  4. CivicaScript® To Distribute Low-Cost Biosimilar To Treat Chronic Inflammatory Conditions 8/5/2025

    CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines to U.S. patients, today announced that it will distribute the biosimilar ustekinumab-aauz, used for treatment of chronic inflammatory conditions in certain patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

  5. Sandoz Signs Non-Binding Term Sheet With Evotec SE To Acquire Its Just-Evotec Biologics In-House Development And Manufacturing Capabilities In Toulouse, France 7/30/2025

    Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced today that it has signed a non-binding term sheet with Evotec SE.

  6. Alteogen Receives Positive CHMP Opinion For Aflibercept Biosimilar, 'EYLUXVI® (ALT-L9)' 7/28/2025

    Alteogen Inc. (KOSDAQ:196170) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EYLUXVI® (code name: ALT-L9), a biosimilar referencing Eylea® (aflibercept), co-developed with its subsidiary Alteogen Biologics Inc.

  7. AscellaHealth Service And Infrastructure Enhancements Support Specialty Drug Manufacturers To Protect Market Share Across Brand, Biosimilar And Generic Launches 7/23/2025

    AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, announces service and infrastructure enhancements designed to help specialty and rare disease drug manufacturers respond to accelerating market disruption across the pharmaceutical landscape.

  8. GlycoNex To Participate In BIO Asia-Taiwan 2025 7/21/2025

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced its participation in the 2025 BIO Asia-Taiwan International Conference & Exhibition. The event will take place from July 23-27, 2025, at the Nangang Exhibition Center, Taipei.

  9. Samsung Bioepis Enters Into A Partnership With Harrow For Commercialization Of Ophthalmology Biosimilars Portfolio In The United States 7/17/2025

    Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States.

  10. Bio-Thera Solutions Announces FDA Accepts Biologics License Application For BAT2506, A Proposed Biosimilar To Simponi® 7/16/2025

    io-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab).