Biosimilar Development News

  1. Kyungdong Pharmaceutical And Asimov Announce Completion Of Cell Line Development Campaign For Biosimilar Antibody 8/9/2026

    Kyungdong Pharmaceutical announced that it has successfully completed a cell line development campaign for a biosimilar antibody candidate, in collaboration with Asimov, the company building an AI-native synthetic biology platform to advance therapeutic development.

  2. Biocon Announces U.S. Commercial Launch Of Yesafili, A Biosimilar To Regeneron's Eylea 2 mg 8/3/2026

    Biocon Limited, an innovation‑led global biopharmaceutical company, today announced the commercial launch of Yesafili (aflibercept-jbvf) in the United States.

  3. Fresenius Announces FDA Approval Of Rituximab Biosimilar For The U.S. Market 8/3/2026

    Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL), a biosimilar to Rituxan* (rituximab).1

  4. Polpharma Biologics Announces FDA And EMA Acceptance For Review Of PB016 Vedolizumab Biosimilar Candidate 7/31/2026

    Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

  5. Meitheal Pharmaceuticals Announces FDA Approval Of Garzulys (insulin aspart-fsan) Injection 7/30/2026

    Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys (insulin aspart-fsan) injection, a biosimilar to NovoLog (insulin aspart).

  6. HSCA Applauds House Energy And Commerce Commitee And Senate HELP Commitee For Advancing Bipartisan Biosimilars Legislation That Will Help Increase Access To Safe Medications 7/29/2026

    The Healthcare Supply Chain Association (HSCA) and its traditional healthcare group purchasing organization (GPO) members commend the U.S. House Committee on Energy and Commerce for unanimously advancing two bipartisan bills that would expand patient access to lower-cost biosimilars: the Expedited Access to Biosimilars Act (H.R. 9661), led by Reps.

  7. Alvotech Announces Successful Closure Of FDA Inspection Of Manufacturing Facility 7/29/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026.

  8. Mabwell Established A Licensing And Commercialization Agreement Of Aflibercept Biosimilar For GCC Market 7/29/2026

    Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has established a licensing and commercialization agreement with SVAX Inc., a Saudi Arabian biopharmaceutical company, for its product Aflibercept Biosimilar.

  9. The Biosimilars Forum Commends Members Of The Senate HELP Committee For Supporting Lower-Cost Biosimilars 7/24/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the Senate Committee on Health, Education, Labor and Pensions (HELP) advanced the Expedited Access to Biosimilars Act to lower drug costs by modernizing the development and approval process for biologics to make it more efficient.

  10. The Biosimilars Council And AAM Applaud Senate Markup And Committee Passage Of The Expedited Access To Biosimilars Act 7/23/2026

    The Biosimilars Council and the Association for Accessible Medicines today thanked the Senate HELP Committee for marking up and passing the Expedited Access to Biosimilars Act.