Authorization

Biogen: EMA To Review MAA For BIIB800 - Quick Facts

(RTTNews) - Biogen Inc. (BIIB) announced the European Medicines Agency has accepted the Marketing Authorization Application for BIIB800, a biosimilar candidate referencing RoACTEMRA (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

Ian Henshaw, Head of Global Biosimilars at Biogen, said: "If approved, BIIB800 will be a valuable treatment option for people with chronic immune mediated inflammatory diseases."

On April 8th, 2021, Biogen and Bio-Thera Solutions, entered into a commercialization and license agreement for BIIB800. Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China.

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