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Mylan Presses On With US Tecfidera Launch ‘At Risk’

Follows First FDA Approval For Rival To MS Blockbuster

Executive Summary

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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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.

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