Bio-Thera’s BAT2506 marketing application accepted by FDA
July 21, 2025
Source: drugdu
113
Bio-Thera announced that the biologics license application (BLA) for BAT2506 (golimumab injection) has been accepted by the U.S. Food and Drug Administration (hereinafter referred to as FDA). The drug is a golimumab biosimilar developed by Bio-Thera, and its original drug is Simponi of Johnson & Johnson in the United States. According to Johnson & Johnson's 2024 annual report, Simponi's global sales last year were US$2.19 billion. BAT2506's application for listing has been accepted by regulatory agencies in China, the United States, Europe and Brazil. However, given the lucrativeness of the U.S. pharmaceutical market, if BAT2506 is approved for listing in the United States, the commercial returns of the drug are expected to increase significantly.
https://www.nbd.com.cn/articles/2025-07-16/3947861.html
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