Mylan has launched the first FDA-approved generic version of Biogen’s dimethyl fumarate (Tecfidera) for relapsing forms of multiple sclerosis.
Mylan has launched the first FDA-approved generic version of Biogen’s dimethyl fumarate release 120 mg and 240 mg capsules (Tecfidera), which are indicated for the treatment of relapsing forms of multiple sclerosis (MS), according to a press release.
Mylan’s generic is the first of any MS treatment in an oral solid dosage form available to patients in the United States.
The launch follows Mylan’s win in the US District Court for the Northern District of West Virginia that invalidated Biogen’s Tecfidera patent. Biogen is appealing the decision.
“The launch of the first generic Tecfidera is yet another prime example of Mylan’s fundamental commitment to bringing more access to patients worldwide, in this particular case through our continued support of the MS community, while helping to provide immediate and substantial savings for the US healthcare system,” said Heather Bresch, CEO of Mylan. “It also represents another significant achievement for the many Mylan scientific, regulatory, and legal colleagues who continue to work tirelessly in doing their part to bring important access to medicines as quickly as possible.”
Dimethyl fumarate oral delayed-release capsules were originally approved by the FDA in 2013 as the third oral drug indicated for the treatment of relapsing forms of MS.
Mylan Brings Critical Access to the Multiple Sclerosis Community by Launching a More Affordable Treatment Option Through a First Generic to Tecfidera. News Release. Mylan; August 19, 2020. Accessed August 20, 2020. http://newsroom.mylan.com/2020-08-19-Mylan-Brings-Critical-Access-to-the-Multiple-Sclerosis-Community-by-Launching-a-More-Affordable-Treatment-Option-Through-a-First-Generic-to-Tecfidera-R