Updated: Mylan Presses On With US Tecfidera Launch ‘At Risk’
Follows First FDA Approval For Rival To MS Blockbuster
Facing an appeal on a favorable US district court decision, Mylan has opted to launch “at risk” the first generic Tecfidera in the US, after obtaining FDA approval and seeing the originator’s bid for injunctive relief shot down earlier this month.
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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.
As anticipated by the street, Viatris has prevailed over Biogen on the originator’s appeal of a district court ruling that invalidated a key US patent shielding its Tecfidera treatment for multiple sclerosis. However, the Federal Circuit was not aligned on its decision.
Sandoz has announced its launch of a generic rival to Tecfidera in Canada, with the firm among the first generics to be issued a notice of compliance by Health Canada.