Biosimilar Development News

  1. Sandoz Files Antitrust Litigation Against Amgen Regarding Patient Access To Etanercept Biosimilar In The US 4/15/2025

    Sandoz, the global leader in generic and biosimilar medicines, today announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998.

  2. Biocon Biologics Secures Market Entry Date For Yesafili, An Interchangeable Biosimilar To Eylea, In The U.S. 4/15/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced today a settlement and license agreement with Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept, in the United States.

  3. Budget Impact Analysis Presented At IMKASID 2025 Shows Opportunity To Reduce Budgetary Pressures And Improve Treatment Accessibility With Ustekinumab Biosimilars In Europe 4/10/2025

    Samsung Bioepis Co., Ltd. today presented two sets of data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the United Kingdom (UK) and Sweden and the real-world safety and effectiveness of adalimumab biosimilar in South Korea at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea.

  4. Biocon Biologics Announces U.S. FDA Approval For Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio 4/10/2025

    Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab).

  5. Biosimilars Council Executive Director Craig Burton Testifies Before Congress On Biosimilars Crisis 4/8/2025

    The Biosimilars Council today released Congressional testimony provided by Craig Burton, Executive Director of the Biosimilars Council before the House Ways & Means Health Subcommittee hearing: Lowering Costs for Patients: The Health of the Biosimilar Market.

  6. Biosimilars Forum Urges Congressional Action On Biosimilars 4/8/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the House Ways and Means Health Subcommittee hearing on “Lowering Costs for Patients: The Health of the Biosimilar Market.”

  7. Teva And Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available In The United States 4/8/2025

    Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

  8. Biosimilars Forum Supports The FDA, Its Employees, And Its Mission 4/2/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement about the U.S. Food and Drug Administration (FDA) and its recent loss of institutional knowledge and expertise through reductions in force.

  9. Accord Healthcare Receives Positive CHMP Opinion For Denosumab, Osvyrti®, And Jubereq® 4/2/2025

    Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti® and Jubereq®, across its autoimmune and oncology therapy areas.

  10. UK Medicines And Healthcare Products Regulatory Agency Confirms Acceptance Of Marketing Authorization Application For Proposed Biosimilar To Xolair® (omalizumab) 3/28/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion [1].