Mylan Launches First U.S. Generic of Biogen MS Drug Tecfidera
August 19 2020 - 8:09AM
Dow Jones News
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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