Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
March 16 2023 - 6:30AM
Biogen Receives Favorable Decision from Court of Justice of the
European Union Relating to TECFIDERA® (dimethyl fumarate)
Regulatory Data and Marketing Protection
Biogen Inc. (Nasdaq: BIIB) today announced that the Court of
Justice of the European Union decided in favor of Biogen, the
European Medicines Agency (EMA), and the European Commission in
their appeal of a General Court decision annulling the EMA’s
refusal to evaluate a generic version of TECFIDERA® (dimethyl
fumarate) because of TECFIDERA’s regulatory data and marketing
protection. With this favorable decision, Biogen believes that
TECFIDERA is entitled to regulatory marketing protection in the
European Union until at least February 4, 2024. Biogen will seek to
enforce this protection and continue to enforce its EP 2 653 873
patent related to TECFIDERA, which expires in 2028.
Biogen’s Full Year 2023 Financial Guidance issued on February
15, 2023, assumed a favorable decision such as this in this
case.
About BiogenFounded 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, and two co-developed treatments to address
a defining pathology of Alzheimer’s disease. 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
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MEDIA CONTACT:BiogenJack Cox+ 1
210 544 7920public.affairs@biogen.com |
INVESTOR CONTACT:BiogenMike
Hencke+1 781 464 2442IR@biogen.com |
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