July 18, 2025
Source: drugdu
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On July 16, Bio-TheraThe company announced that it had recently received the BAT2506 (golimumab) injection biologicThe drug licensing application (BLA) has been accepted by the U.S. Food and Drug Administration (FDA). Its indications include active ankylosing spondylitis (AS), combined with methotrexate for the treatment of moderately to severely active rheumatoid arthritis (RA), moderately to severely active ulcerative colitis (UC) that is dependent on corticosteroids or has insufficient response or intolerance to other treatment options, etc.
The announcement shows that BAT2506 (golimumab) injection is a golimumab biosimilar developed by Bio -Thera in accordance with the relevant guidelines of the National Medical Products Administration, the US FDA, and the European EMA for biosimilars. Golimumab is an antibody targeting TNF-α, which can specifically bind to soluble and transmembrane human TNF-α with high affinity, blocking the binding of TNF-α to its receptor TNFR, thereby inhibiting the activity of TNF-α.
It is reported that the original drug of BAT2506 (golimumab injection) is from Johnson & Johnson of the United States.The company's Simponi. According to Johnson & Johnson's 2024 annual report, Simponi's global sales in 2024 are US$2.19 billion.
Currently, Bio-Thera has launched the commercialization process of BAT2506 (golimumab) injection in many regions around the world. Bio-Thera's partner companies include Pharmapark LLC, SteinCares, etc., and the authorized cooperation areas include the United States, Brazil, Russia, Cambodia, Indonesia, Malaysia and other places.
As of July 16, the marketing authorization application for BAT2506 injection has been accepted by China's NMPA, the U.S. FDA, Europe's EMA, and Brazil's ANVISA.
https://finance.eastmoney.com/a/202507163459030142.html
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