This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA. TOFIDENCE was approved by the FDA in September 2023.
TOFIDENCE is an intravenous formulation of an interleukin-6 receptor antagonist, and is approved for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. Under a 2021 licensing agreement between Biogen and Bio-Thera, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries, except China.