Biosimilar Development News

1. 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.

2. 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.

3. 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.

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. 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.

7. 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.

8. 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.

9. First Patient Dosed In China For International Multi-Centre Phase 1 Clinical Trial Of Henlius' Nivolumab Biosimilar HLX18 7/16/2026

   Henlius (2696.HK) announced that the first patient in China has been dosed in the international multicenter Phase 1 clinical trial (HLX18-MRST001) of its self-developed nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) in patients with resected solid tumors.

10. Samsung Bioepis And Organon Broaden Biosimilar Access In Australia Through Expanded Commercialisation Agreement 7/16/2026

    Samsung Bioepis Co., Ltd. and Organon, a global healthcare company with deep expertise in biosimilars, have announced the expansion of their Development and Commercialisation Agreement, to commercialise a new biosimilar in Australia by Organon ANZ.