Bio-Thera: BAT2506 (golimumab) injection marketing authorization application accepted by the U.S. FDA

2025-07-16 15:42:17

Bio-Thera announced that the company recently received a notice that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for BAT2506 (golimumab) injection. The drug is a biosimilar to golimumab, and the original drug is Simponi (Ximponi) of Johnson & Johnson, with global sales of US$2.19 billion in 2024. Bio-Thera has cooperated with many companies to carry out the commercialization process of BAT2506 (golimumab) injection in multiple regions. The drug marketing authorization application has been accepted by China NMPA, US FDA, European EMA, and Brazilian ANVISA.

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