Bio Thera files for China approval of Actemra biosimilar

10 November 2021

Chinese biotech Bio Thera Solutions (688177 SH) has filed a new drug application (NDA) with China’s National Medical Products Administration (NMPA) to gain approval of what would be the country's first biosimilar of Actemra (tocilizumab).

The biosimilar was in-licensed from US biotech Biogen (Nasdaq: BIIB) in April. Originated by Swiss pharma giant Roche (ROG: SIX), Actemra was approved in China in 2016 to treat rheumatoid arthritis and other diseases, such as systemic juvenile idiopathic arthritis.

Global sales Actemra/RoActemra rose 30% year-on-year to 2.69 billion Swiss francs ($2.95 billion) for the first nine months of the current year.

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