Bio-Thera Solutions Receives the NMPA’s Approval of BAT1806, a Biosimilar to Actemra
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.