Mylan on Wednesday announced plans to launch a generic version of Biogen’s top-selling drug, the oral multiple sclerosis medicine Tecfidera.Mylan chose to launch the generic following a district court ruling that invalidated a key patent covering Biogen’s drug. But Mylan is doing so “at risk,” meaning the company could be vulnerable if it loses an appeal that a Biogen spokesperson confirmed is “pending.” The announcement came just a day after the FDA approved Mylan’s copycat Tecfidera.The move puts more pressure on Biogen, which is already being tested on multiple fronts. And it could signal changes in the U.S. market for multiple sclerosis treatments, should a Delaware court rule against Biogen in a separate dispute and clear the way for more generic copies.
Mylan won a surprising victory in June when a West Virginia District Court overturned a key Tecfidera patent that was set to expire in 2028. That ended a string of court successes for Biogen, which has defended its top drug multiple times, including from a previous Mylan challenge in a separate U.S. Patent and Trade Office dispute.
The ruling left Biogen vulnerable, as the only other patent covering Tecfidera has expired.
Analysts expected the setback would set the stage for generic competition as early as next year. But Mylan has jumped ahead and launched, even though Biogen’s appeal could in theory reverse the district court’s decision.
Mylan’s generic dimethyl fumarate is the first generic of an oral drug for multiple sclerosis to become available. Others could soon follow: Biogen is facing multiple other patent challenges in Delaware, with a verdict expected soon. Baird analyst Brian Skorney noted Mylan’s decision to move ahead signals its confidence that the Delaware court will also rule against Biogen.
A rejected appeal would set back Biogen, but could also pressure the overall market for branded multiple sclerosis drugs, Skorney wrote, citing his expectation Tecfidera generics could become commonly prescribed.
Biogen is facing increasing competition on other fronts, too. A new self-injectible multiple sclerosis drug from Novartis, ofatumumab, could be approved next month and is expected to take market share away from the Roche drug Ocrevus, from which Biogen draws a royalty.
Biogen’s Tecfidera successor Vumerity, meanwhile, generated just $7 million in its first two quarters on the market.
The company’s spinal muscular atrophy drug Spinraza, another top-seller, faces two competing medicines, due to the recent approval of Roche’s Evrysdi.
That’s made the potential approval of aducanumab, an Alzheimer’s drug with mixed clinical results, “more important than ever as it relates to keeping the Biogen ship afloat,” Skorney wrote. An FDA decision is expected by next March.
Biogen shares ticked down 2% on Wednesday.