NEW YORK: Teva Pharmaceutical Industries Ltd said Friday it aims to win U.S. approval by late 2017 or early 2018 for its version of Mylan NV's EpiPen device for treating severe allergic reactions, a move that would challenge the branded product's overwhelming market dominance.
EpiPen's list price has soared from less than $100 when Mylan acquired the product in 2007, to more than $600 now, sparking outrage from patients, consumers and politicians.
But without strong competitors, Mylan's EpiPen still holds an estimated 94 percent market share in the United States.
Teva's application for a copycat version has been in question since February, when the Food and Drug Administration flagged "major deficiencies" in the Israeli drugmaker's device.
"We requested a meeting with the FDA," Sigurdur Olafsson, Teva's head of global generic medicines, said in a webcast overview of the company's generics medicines business. He said Teva did not get a response, but after "the media attention in the last two weeks, the FDA has come back to us and we will have a meeting very, very quickly." Given the recent "political noise on EpiPen," the FDA may now be more inclined to approve Teva's generic version, Evercore ISI analyst Umer Raffat said in a webcast message to clients. Analysts had expected Teva to alter its autoinjector's design to remedy a dosing issue cited by the FDA, but Olaffson said the company was not planning any modifications to its device at this point.
