Biogen Reports the US FDA’s Acceptance of Abbreviated BLA of BIIB800 (biosimilar, tocilizumab) for Rheumatoid Arthritis
Shots:
- The US FDA has accepted aBLA for review of BIIB800, an ACTEMRA biosimilar. If approved, BIIB800 will be used for the treatment of incl. RA, idiopathic polyarthritis, idiopathic arthritis & sclerosis-associated ILD
- The filing was based on the P-III trial assessing BIIB800 vs ACTEMRA in 621 patients with RA with an inadequate response to methotrexate. The results showed an equivalent efficacy & comparable safety and immunogenicity profile to the reference tocilizumab
- Under the April 2021 agreement with Bio-Thera Solutions, Biogen gains exclusive worldwide regulatory, manufacturing & commercial rights of BIIB800 except China (incl. Hong Kong, Macau & Taiwan)
Ref: Globenewswire | Image: Biogen
Related News:- Biogen Reports the EMA Acceptance of MAA for BIIB800 (biosimilar, tocilizumab)
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