Hours after blockbuster patent win, Mylan asks the FDA to speed up an OK to market a generic to Biogen’s Tecfidera
Hours after Biogen was handed a key defeat in federal court, losing patent protection that would have protected the multibillion-dollar franchise drug Tecfidera to 2028, Mylan jumped in with a plan to ask the FDA for an accelerated OK of its copycat drug.
Looking at carving up a market that delivered $4.4 billion of Biogen’s revenue last year — 39% of the big biotech’s total — Mylan doesn’t want to wait 5 months for a scheduled decision from the agency.
“The District Court decision clears the legal pathway for us to bring our dimethyl fumarate product to market, and we are working with the FDA to accelerate our regulatory approval target action date, which currently is November 16,” says CEO Heather Bresch. “Once approved and launched, we believe our generic Tecfidera will potentially be the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S. …”
Analysts have been wondering whether Mylan was ready to launch the rival “at risk,” leaving them open to a considerable sanction if Biogen should win an appeal. But several also score this as Mylan’s fight for now, with Biogen losing control of a market that has sustained the company for years.
For Biogen, the looming arrival of a generic to Tecfidera raises more big questions for a company facing a major delay filing their controversial Alzheimer’s drug aducanumab after triggering a super spreader event that accelerated the epidemic of Covid-19 in the US. None of the analysts have been satisfied with the business deals they’ve done, with growing expectations that Biogen CEO Michel Vounatsos would do something big.
Those expectations continue to grow.