Bio-Thera Solutions Receives the NMPA’s Approval of BAT1806, a Biosimilar to Actemra
Shots:
- The NMPA has approved BAT1806, a biosimilar of Actemra (tocilizumab) in China for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome
- BAT1806 is highly similar to the reference drug in terms of quality, safety, and efficacy acc. to extensive analytical similarity, non-clinical similarity & clinical studies
- The additional biosimilar products are being developed by the company, incl. proposed biosimilars for Simponi, Stelara, and Cosentyx, which are all undergoing in the P-III study, and a proposed biosimilar for Nucala in the P-I study. The US FDA & EMA has accepted the MAA of BAT1806/BIIB800
Ref: Businesswire | Image: Bio-Thera Solutions
Related News:- Bio-Thera Solutions Reports the NMPA's Acceptance of MAA for BAT1806 (biosimilar, tocilizumab) to Treat Rheumatoid Arthritis
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