The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid — capsule or tablet — form in the U.S.
Generics are nearly identical versions of an original branded medication. They are typically sold at lower prices than brand-name medicines, and they can reduce costs generally by introducing competition to the market.
“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 important continued support of the MS community, while helping to provide immediate and substantial savings for the U.S. healthcare system,” Heather Bresch, CEO of Mylan, said in a press release.
“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,” Bresch added.
The active ingredient in Tecfidera — a therapy marketed by Biogen — is dimethyl fumarate, which is believed to work by reducing the activity of the immune system. The new generic contains this same active ingredient, available as delayed release capsules at 120 mg and 240 mg doses.
FDA approval of the new generic followed a ruling by the District Court for the Northern District of West Virginia, which invalidated the patent that had protected Tecfidera from generic competition. Without this invalidation, a generic was not likely to become available before 2028, when Biogen’s patent was set to expire.
Biogen, however, has stated that it is appealing this court ruling.
“Our commitment to the MS community stems all the way back to our initial investment in 2009 to bring a first generic Copaxone [glatiramer acetate injection] to market, which we achieved in 2017. Today’s launch represents yet another example of that commitment, by bringing access to the first generic of Tecfidera,” said Rajiv Malik, president of Mylan.
“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. I too would like to thank all of my colleagues for their passion and support in fulfilling our company’s mission to expand access to high quality medicines,” Malik added.
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