Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
baona/iStock via Getty Images


Biogen (NASDAQ:BIIB) said that the Court of Justice of the EU decided in favor of the company, the European Medicines Agency (EMA), and the European Commission (EC) in their appeal of a General Court decision annulling the EMA's refusal to evaluate a generic version of multiple sclerosis drug Tecfidera.

Biogen said the decision was made because of its drug Tecfidera's (dimethyl fumarate) regulatory data and marketing protection.
Following the decision, Biogen believes that the drug would be eligible for regulatory marketing protection in the EU until at least Feb. 4, 2024.
Biogen added that it will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to the therapy which expires in 2028.
The company noted that its full Year 2023 financial outlook, reported along with its Q4 results, expected a favorable decision such as this, in this case.