Biogen wins EU exclusivity for Tecfidera until 2025
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Biogen (NASDAQ:BIIB) announced Wednesday that the European Commission notified the company that the regulatory market protection for its blockbuster multiple sclerosis therapy Tecfidera extends until February 2, 2025.

The decision grants Biogen (BIIB) the exclusive rights to commercialize Tecfidera in the region for the period without the threat of copycats containing the same active ingredient(s).

In March, the EU Court of Justice sided with Biogen (BIIB) and other regulators, including European Medicines Agencyâs (EMA) in an appeal related to a General Court decision annulling EMAâs refusal to evaluate a Tecfidera generic.
Referring to the verdict, the company argued at the time that it is entitled to regulatory marketing protection for Tecfidera until at least February 4, 2024, in the EU.
Biogen (BIIB) reported $1.4B Tecfidera sales in 2022, indicating a ~26% YoY decline as the drug generated $1.0B overseas, with a ~19% YoY drop.


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