FX.co ★ Biogen's Tofidence Gets Positive CHMP Opinion For Rheumatoid Arthritis,Juvenile Arthritis & COVID-19

Biogen Inc. has announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has put forward a supportive recommendation for Tofidence (tocilizumab), a biosimilar monoclonal antibody, originally modeled after Roactemra.

The CHMP proposes that the intravenous formulation of Tofidence should be approved for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Based on the CHMP's positive opinion, the European Commission will now determine whether to grant marketing authorization for Tofidence.

Should the European Commission approve the authorization, Tofidence will supplement Biogen's existing biosimilar portfolio in Europe, which currently includes three widely prescribed anti-TNF biosimilars: Benepali (etanercept), Imraldi (adalimumab), and Flixabi (infliximab).

In April 2021, Biogen and Bio-Thera entered into a commercialization and licensing agreement for Tofidence (BAT1806/BIIB800). According to this deal, Bio-thera's developed drug, Tofidence, will be marketed by Biogen in the European Union. Biogen will exclusively regulate, manufacture, and commercialize Tofidence in all countries, with the exception of China, including Hong Kong, Macau, and Taiwan.

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