Biosimilar Development News

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Accord BioPharma Announces Commercial Availability Of Denosumab Biosimilars OSVYRTI® (denosumab-desu) And JUBEREQ® (denosumab-desu) 7/23/2026

    Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology and central nervous system (CNS) therapies, today announced the launch of two denosumab biosimilars—OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)—expanding access to more affordable therapies for patients.

  9. The Biosimilars Forum Commends Members Of The House Of Representatives Energy & Commerce Committee For Supporting Lower-Cost Biosimilars 7/23/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the House Energy & Commerce Committee voted unanimously to move to the floor the Expedited Access to Biosimilars Act and the Biosimilar Red Tape Elimination Act, which are bipartisan bills that would increase access to biosimilars to Americans that need them.

  10. BioSim Welcomes The Reception Of Its Main Proposals In The New Medicines Act, But Expresses Caution Regarding The Practical Application Of Dynamic Pricing 7/23/2026

    The Spanish Association of Biosimilar Medicines (BioSim) expresses its satisfaction following the publication of the final text of the Draft Law on Medicines and Medical Devices.