1. Generics Bulletin

US Tecfidera Sales Could Plunge By $2.8bn In 2021

Market Reacts To Mylan ‘At-Risk’ Launch

 
• By Dean Rudge

Generic competition to the one of the most lucrative small-molecule opportunities in the US arrived as Mylan pushed on with an “at-risk” launch to Biogen’s Tecfidera. Mylan’s fortunes and the ramifications of parallel litigation in a separate court were speculated by investors in the wake of the news.

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Tecfidera revenues will greatly diminish if Mylan and other generics flood the market • Source: Shutterstock

Mylan’s “at-risk” launch of the first generic version of Biogen, Inc’s. Tecfidera (dimethyl fumarate) could cost the originator almost $3bn in lost annualized revenues by the end of 2021, according to a US healthcare investor.

With Mylan’s announced launch on 19 August, SVB Leerink in a 19 August note said it was “lowering our US Tecfidera sales from $3.4bn to $2

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