EC revokes centralized authorizations of Tecfidera generics

19 December 2023
tecfidera-packaging-biogen-big

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Generics