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Mylan secures first FDA approval for generic version of Biogen's Tecfidera following patent dispute

Published on 20/08/20 at 12:20pm

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is launching the drug in a dimethyl fumarate delayed-release oral solid formulation, both in 120mg and 240mg doses.

Mylan was quick to celebrate the decision and what it means for MS patients, though no information on the price of the drug was forthcoming.

“Our commitment to the MS community stems all the way back to our initial investment in 2009 to bring a first generic Copaxone to market, which we achieved in 2017,” commented Mylan President Rajiv Malik. “Today's launch represents yet another example of that commitment, by bringing access to the first generic of Tecfidera. While we are pleased with our accomplishments to date, we remain equally excited to expand our offerings by advancing work on a co-developed follow-on product for a once-monthly glatiramer acetate injection.”

The approval follows just one month after Mylan triumphed in the US District Court for the Northern District of West Virginia to invalidated Biogen’s patent on Tecfidera, though the company is appealing the decision. The drug generated $3.79 billion for Biogen through 2019.

Matt Fellows

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