Mylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval

Mylan has received FDA approval for its generic version of Biogen’s Tecfidera (dimethyl fumarate), a blockbuster drug for treating relapsing forms of multiple sclerosis (MS).

The copycat drug, the first oral solid-dosage generic of any MS treatment to earn FDA approval, was caught up in a federal court case that ultimately led to the invalidation of Biogen’s Tecfidera patent and a Mylan victory.

Mylan has now launched the product in 120mg and 240mg delayed-release capsule forms.