Biosimilar Development News

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Organon Canada Announces The Appointment Of Dominic Bégin As President And Managing Director 7/22/2026

    Organon Canada, a global healthcare company dedicated to improving the health of women, is pleased to announce the appointment of Dominic Bégin as President and Managing Director.

  9. The Biosimilars Council And AAM Lauds House Markup Of Expedited Access To Biosimilars Act And Biosimilars Red Tape Elimination Act 7/21/2026

    The Biosimilars Council and the Association for Accessible Medicines today lauded legislative progress as the House Energy and Commerce Committee marked up and voted to approve the Expedited Access to Biosimilars Act and the Biosimilars Red Tape Elimination Act.

  10. Samsung Bioepis And Harrow Present Interim Data From A Large-Scale Post-Marketing Surveillance Study On SB11 (BYOOVIZ® / AMELIVU®), A Biosimilar To Lucentis (ranibizumab), At ASRS 2026 7/20/2026

    Samsung Bioepis Co., Ltd. and Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, presented interim data from a post-marketing surveillance (PMS) study on SB11 (US brand name: BYOOVIZ®, Korea brand name: AMELIVU®), a biosimilar referencing Lucentis1, at the 44th Annual Meeting of the American Society of Retina Specialists (ASRS), held in Montréal, Canada, July 15–18, 2026.