Biogen Triumphs In Legal Battle Regarding Tecfidera, Delaying EU Generic Erosion For Another Year

  • The Court of Justice of the European Union favored Biogen Inc BIIB regarding its appeal of a General Court decision annulling the European Medicines Agency's (EMA) refusal to evaluate a generic version of Tecfidera due to regulatory data and marketing protection.
  • Tecfidera (dimethyl fumarate) is a prescription medicine for treating relapsing multiple sclerosis (MS) forms. 
  • Tecfidera is now entitled to regulatory marketing protection in the European Union until at least February 4, 2024, and Biogen will seek to enforce this protection through 2028 with additional patent protection. 
  • The company said FY23 guidance assumed a favorable decision for Tecfidera.
  • William Blair increased 2023 Tecfidera projections to reflect patients switching back to branded Tecfidera, where generics had been marketed and reduced erosion for the year. 
  • In 2022, Tecfidera generated sales of $1.44 billion, down from $1.95 billion in 2021.
  • Beyond Tecfidera, Biogen anticipates significant regulatory and commercial catalysts in 2023, beginning with the full approval of the July 6 PDUFA for Leqembi. The analyst also notes CMS potentially revisiting the currently restrictive NCD after full approval as the most significant commercial catalyst. 
  • The AdCom for Tofersen in SOD1-ALS is also being held next week on Wednesday, March 22, and will be necessary for setting an additional regulatory precedent for ALS for Biogen and partner Ionis Pharmaceuticals Inc IONS.
  • Price Action: BIIB shares are up 1.56% at $266.47 on the last check Thursday.
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