EC revokes all centrally granted generic marketing permissions for DMF
Biogen notches another Tecfidera patent win in Europe
After failing to block generics for Tecfidera in the US, Biogen snagged a win in Europe in its fight to prevent copycat versions of its blockbuster multiple sclerosis drug.
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- 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.
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In going all the way to the United States Supreme Court in a bid to reinstate the patent of blockbuster drug Tecfidera, Biogen was throwing a desperation Hail Mary.
Biogen has reached an agreement in principle to pay $900 million to resolve a whistleblower suit dating back to 2015, the company said Wednesday. The suit alleges that the company paid kickbacks to doctors to increase prescriptions of Biogen’s multiple sclerosis drugs Tecfidera, Tysabri and Avonex.
Monday, The Chemistry and the Law Division (CHAL) of the American Chemical Society put its chips behind Biogen, whose once-stalwart multiple sclerosis franchise is already feeling the sting of generics from Mylan, now known as Viatris. Meanwhile, copycats from other generic drugmakers, such as Lupin and Glenmark, are circling the gates.