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

(RTTNews) - Biogen Inc. (BIIB) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA adopted a positive opinion for Tofidence (tocilizumab), 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, which will decide whether to grant marketing authorization for Tofidence.

If a marketing authorization is granted by the European Commission, Tofidence will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe. They are Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab).

Biogen and Bio-Thera reached a commercialization and licensing agreement for Tofidence (BAT1806/BIIB800) in April 2021. As per the deal, 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 (including Hong Kong, Macau and Taiwan).

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