Biogen Faces Setback as Europe Revokes Marketing Authorization for Tecfidera Generics

In a significant development, Biogen Inc. announced on Tuesday that the European Commission has revoked the marketing authorization for generic versions of its flagship multiple sclerosis drug, Tecfidera. The authorization was held by pharmaceutical firms Accord, Neuraxpharm, Polpharma, and Teva.

While the patent for Tecfidera has already expired in the United States, Biogen secured a crucial victory in Europe in March when the EU’s Court of Justice blocked generic versions of the drug in the region. In May, Biogen expressed confidence that Tecfidera would enjoy market protection in Europe until February 2025.

Tecfidera has been a leading product for Biogen in the multiple sclerosis treatment market, but it has faced increasing competition, particularly in the United States. The revocation of marketing authorization for generic versions in Europe adds to the challenges for Biogen, emphasizing the competitive landscape and the company’s efforts to protect its market share.

This development underscores the complexities of intellectual property protection and market dynamics in the pharmaceutical industry, with Biogen navigating legal avenues to maintain its position in the European market. The decision by the European Commission marks a setback for generic manufacturers seeking to enter the market with their versions of Tecfidera.

As the situation unfolds, industry observers will be closely monitoring Biogen’s strategic responses and the potential implications for the company’s market performance in Europe.

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