Posted by Michael Wonder on 22 Dec 2023
Centralised marketing authorisations of generic versions of Tecfidera are revoked by the European Commission
19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions of Biogen’s product Tecifdera (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and 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.
