Biogen Inc. announced that the European Medicines Agency has accepted the Marketing Authorization Application for BIIB800, a biosimilar candidate referencing RoACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. RoACTEMRA® is indicated in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate, moderate to severe rheumatoid arthritis in adults who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists, as well as for the treatment of patients from 2 years of age with juvenile idiopathic polyarthritis who have responded inadequately to previous therapy with methotrexate, patients from 2 years of age with active systemic juvenile idiopathic arthritis who have responded inadequately to prior therapy with NSAIDs and systemic corticosteroids. RoACTEMRA® is also used to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults or paediatric patients 2 years of age or older, and severe coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The MAA includes positive Phase 32 data for BIIB800 from the clinical program of a multicenter, multinational, randomized, double-blind, parallel-group, active-control study, designed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of BIIB800 compared to RoACTEMRA® in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate. The Phase 3 data from the comparative clinical trial demonstrated that the biosimilar candidate BIIB800 has equivalent efficacy and a comparable PK, safety and immunogenicity profile to reference tocilizumab and these positive results were presented at the European Congress of Rheumatology on June 3, 2022. On April 8th, 2021, Biogen and Bio-Thera Solutions Ltd. entered into a commercialization and license agreement to develop, manufacture and commercialize BIIB800.

Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China (including Hong Kong, Macau and Taiwan). Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator's reference product, with the advantage that they offer cost savings and promote sustainable access to therapies. Biogen is committed to advancing development, manufacturing and commercialization of additional biosimilar candidates with the goal of optimizing the disease management with biosimilars and helping more people and healthcare systems across the world to benefit from biologics treatments.