Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission

CAMBRIDGE, Mass., Dec. 19, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva.

In reaching this decision, the European Commission affirmed that Biogen is entitled to full data protection and marketing protection for TECFIDERA. Biogen welcomes the actions of the European Commission, which confirm the laws governing data exclusivity and marketing protection. Those laws are essential to protecting innovation.

TECFIDERA is entitled to marketing protection until February 3, 2025, and is the only dimethyl fumarate treatment for multiple sclerosis that may be lawfully placed on the market for sale in the EU until that date. Biogen has initiated legal action to defend its market protection rights. Biogen has sufficient supply of TECFIDERA to supply the entire European market.

About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, two co-developed treatments to address a defining pathology of Alzheimer’s disease, the first treatment to target a genetic form of ALS, the first oral treatment approved for postpartum depression, and the first approved treatment for Friedreich’s ataxia. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

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This news release contains forward-looking statements about the Biogen’s supply of Tecfidera; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs; and risks and uncertainties associated with drug development and commercialization, including data exclusivity and marketing protection. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.

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