EC revokes centralized authorizations of Tecfidera generics

19 December 2023

US biotech major Biogen (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate), held by Accord, Mylan (Nasdaq: MYL), Neuraxpharm, Polpharma and Teva Pharmaceutical Industries (NYSE: TEVA).

In reaching this decision, the European Commission affirmed that Biogen is entitled to full data protection and marketing protection for Tecfidera. Biogen said it welcomes the actions of the European Commission, which confirm the laws governing data exclusivity and marketing protection. Those laws are essential to protecting innovation, it pointed out.

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 European Union until that date.

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