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Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16th May 2026.
About this update from Bio-thera Solutions, Ltd. Class A
[{"type":"text","content":"GUANGZHOU, China, July 16, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16th May 2026.","length":459,"tagName":"p"},{"type":"image","alt":"Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. (PRNewsfoto/Bio-Thera Solutions, Ltd)","displaySize":"","headline":null,"caption":"Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. (PRNewsfoto/Bio-Thera Solutions, Ltd)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":209,"url":"https://media.zenfs.com/en/prnewswire.com/5dcaa2a938f74c36f27e3fbb7b39275b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dzycamzHTMsuwCYxDRsNuA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM2ODtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/5dcaa2a938f74c36f27e3fbb7b39275b","width":400,"height":209}},"href":"https://mma.prnewswire.com/media/2332090/3Bio_Thera_LOGO_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The BLA was submitted by Bio-Thera's US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA. Accord BioPharma filed the BLA with FDA on 16th May 2025. The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) ac...