Biogen announces CHMP opinion recommending Tofidence

Biogen announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted an opinion for Tofidence, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of Tofidence has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.The CHMP’s positive opinion will now be referred to the European Commission, or EC, which will decide whether to grant marketing authorization for Tofidence. If a marketing authorization is granted by the EC, Tofidence will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI, IMRALDI and FLIXABI, offering an extension to the cost-effective treatment options with an additional mechanism of action. Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China.