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 the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.
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Biogen has been granted new US patents for Tecfidera after generics already launched. It's unclear how Biogen will proceed but management could shed more light on the matter during the first quarter call.
Mylan’s “at-risk” launch of a generic version of Biogen’s Tecfidera could cost the originator dear as generic competition to the one of the most lucrative small-molecule opportunities arrives in the US.
Mylan is a step closer to realizing launch of a generic version of Biogen’s $3.3bn Tecfidera (dimethyl fumarate) multiple-sclerosis brand in the US after the originator was denied an injunction pending its appeal of an unfavorable patent decision at the district court level.