Biogen wins EU exclusivity for Tecfidera until 2025

• 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 Agency’s (EMA) in an appeal related to a General Court decision annulling EMA’s 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.

More on Tecfidera

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