Mylan Launches First U.S. Generic of Biogen MS Drug Tecfidera

By Colin Kellaher

Mylan N.V. on Wednesday said it has launched its generic version of Biogen's blockbuster multiple-sclerosis drug Tecfidera in the U.S. after receiving approval from the Food and Drug Administration.

Mylan said its dimethyl fumarate delayed-release capsules, indicated for the treatment of relapsing forms of multiple sclerosis, are the first generic of any multiple-sclerosis treatment in an oral solid-dosage form available in the U.S.

Mylan, which has been attacking Biogen's patents in a bid to launch a generic version of the company's biggest drug, won a major decision in June when a U.S. district court in West Virginia ruled that Biogen's patent claims were invalid.

Biogen has vowed to appeal the ruling, and Mylan's launch of its generic version before final appeals is known as an "at risk" move, as the company would owe damages for infringing sales if a higher court restores Biogen's patent.

Tecfidera accounted for roughly 32% of Biogen's second-quarter revenue of $3.68 billion.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 19, 2020 07:54 ET (11:54 GMT)

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