Posted by Michael Wonder on 30 Sep 2022
Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab), an anti-interleukin 6 receptor monoclonal antibody.
The marketing authorisation application includes positive Phase 3 data for BIIB800 from the clinical program of a multi-centre, multinational, randomised, double-blind, parallel-group, active-control trial, designed to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of BIIB800 compared to RoActemra in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate.
