百奥泰：BAT2506（戈利木单抗）注射液上市许可申请获美国FDA受理

Core Viewpoint - The company has received notification from the FDA regarding the acceptance of the Biologics License Application (BLA) for BAT2506 (Golimumab injection), a biosimilar to Janssen's Simponi, which is projected to have global sales of $2.19 billion in 2024 [1] Group 1 - The drug BAT2506 is a biosimilar to Simponi, which is developed by Johnson & Johnson [1] - The company has established collaborations with multiple firms to advance the commercialization of BAT2506 in various regions [1] - The drug's marketing authorization applications have been accepted by regulatory authorities in China (NMPA), the USA (FDA), Europe (EMA), and Brazil (ANVISA) [1]