Mylan launches Tecfidera generic amid Biogen battle
Mylan launched its generic version of Biogen’s $4 billion-a-year multiple sclerosis drug Tecfidera (dimethyl fumarate) yesterday, August 19.
The launch comes two months after Mylan succeeded in having a key Tecfidera patent invalidated by a US federal court. The patent, US number 8,399,514, was due to expire in 2028.
Biogen, which up until that point had secured a series of successes before the courts, is appealing this decision.
Mylan’s copycat is the first generic of any multiple sclerosis treatment in an oral solid dosage form available to patients in the US, according to the company’s announcement.
Heather Bresch, Mylan’s CEO, said: “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 multiple sclerosis community, while helping to provide immediate and substantial savings for the US healthcare system.”
Mylan’s generic may prove risky, as Biogen’s appeal could reverse the district court's decision.
Rajiv Malik, Mylan’s president, added: “Our commitment to the multiple sclerosis 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. Today's launch represents yet another example of that commitment, by bringing access to the first generic of Tecfidera.”
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