Biogen Inc. (BIIB) announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA held by Accord, Mylan, Neuraxpharm, Polpharma and Teva (TEVA). In reaching this decision, the European Commission affirmed that Biogen is entitled to full data protection and marketing protection for TECFIDERA. Biogen welcomes the actions of the European Commission, which confirm the laws governing data exclusivity and marketing protection. Those laws are essential to protecting innovation. TECFIDERA is entitled to marketing protection until February 3, 2025, and is the only dimethyl fumarate treatment for multiple sclerosis that may be lawfully placed on the market for sale in the EU until that date. Biogen has initiated legal action to defend its market protection rights. Biogen has sufficient supply of TECFIDERA to supply the entire European market.
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