Biogen granted FDA review for Actemra biosimilar
Grandbrothers


Biogen (NASDAQ:BIIB) announced Friday that the FDA accepted its marketing application seeking the U.S. regulatory nod for a cheaper version of Actemra (tocilizumab), a rheumatoid arthritis therapy sold by Roche (OTCQX:RHHBY) (OTCQX:RHHBF).
With its abbreviated Biologics License Application ((aBLA)), Biogen (BIIB) has requested FDA approval for BIIB800, a biosimilar candidate referencing Actemra, which is indicated in the U.S. for conditions such as rheumatoid arthritis and idiopathic polyarthritis.

The aBLA is backed by data from a Phase 3 comparative clinical trial, which demonstrated that BIIB800 had equivalent efficacy and comparable safety and immunogenicity profile to tocilizumab.
Biogen (BIIB) has partnered with China-based biotech company Bio-Thera Solutions to develop, manufacture and commercialize BIIB800 globally.

A marketing authorization application (MAA) for BIIB800 is also currently under review of the European Medicines Agency (EMA).