2023-03-16 07:01:27 ET
- 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 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 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.
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Biogen gets EU court ruling in favor of blocking Tecfidera generic entry