Blow For EU Tecfidera Rivals As Biogen Triumphs In Legal Battle
Follows October 2022 Opinion From Advocate General Of CJEU In Favor Of Biogen
Developers of generic dimethyl fumarate have received a setback after a CJEU ruling in Biogen’s favor gave Tecfidera EU regulatory marketing protection until at least February 2024.
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Biogen CEO Plots A Slow Return To Growth As Revenue Set To Shrink Again In 2023
Christopher Viehbacher told his first earnings call as CEO that a review is under way to reverse Biogen’s fortunes, but noted Leqembi will not be a meaningful contributor while treatment and reimbursement bottlenecks remain.
Biogen Will Assert New Tecfidera Patent Amid Hexal Germany Launch
Biogen has conceded that generics to its Tecfidera treatment for relapsing remitting multiple sclerosis may launch “at risk” in the EU, after the US-based player was recently granted further patent protection until 2028.
Viatris Celebrates As US Court Refuses Tecfidera Review
Viatris has welcomed a decision by the US Court of Appeals for the Federal Circuit not to rehear litigation with Biogen over Tecfidera, after a split decision by the court last year confirmed a patent invalidity ruling that allowed generics to launch in 2020. Biogen told Generics Bulletin it was disappointed with the decision and is evaluating its next steps.