Shots:
The EMA has accepted the MAA for BIIB800, a biosimilar referencing RoACTEMRA (tocilizumab). RoACTEMRA is indicated as an IV formulation for RA & JIA
The MAA was based on the P-III trial evaluating BIIB800 vs RoACTEMRA in 621 patients with mod. to sev. RA with inadequate response to methotrexate which showed that biosimilar BIIB800 was equivalent to the reference tocilizumab in terms of efficacy, PK, safety & immunogenicity profile
On April 2021, Biogen & Bio-Thera collaborated to develop, manufacture & commercialize BIIB800 where Biogen gets exclusive regulatory, manufacturing & commercial rights for BIIB800 in all countries excl. China (incl. Hong Kong, Macau & Taiwan)
Ref: Globenewswire | Image: Biogen
