The EpiPen generic Mylan promised in August amid a pricing firestorm is officially on its way to market. The product—priced at $300 per two-pack, less than half the branded drug’s list price—will hit pharmacy shelves next week, Mylan announced.
The EpiPen copycat is a solution Mylan pledged after Congressional questions about its pricing—which has gone from $100 in 2008 to more than $600—ignited public outcry. Industry watchers, including Wells Fargo analyst David Maris, labeled the copay assistance that Mylan first offered as a “good start” but “not enough,” prompting the company to go a step further.
The announcement of the generic didn’t exactly put out the flames, though, especially considering the later revelation that Mylan had misclassified the epinephrine autoinjector as a generic—subject to lower Medicaid rebates—rather than an “innovator” drug as it should have been.
While Mylan agreed to a quick $465 million settlement with the Justice Department on the matter, some lawmakers are still pushing for answers. Just this week, the House Committee on Energy and Commerce and the Senate Finance Committee demanded to know why Center for Medicare and Medicaid Services officials didn’t force Mylan to fix the EpiPen rebate problem, despite knowing about it for years.
Mylan CEO Heather Bresch, meanwhile—who has declined to attend a Congressional hearing about the Justice Department settlement—has maintained publicly that it’s up to policymakers to increase transparency on how drugs are priced so consumers know where their money’s going.
"Unfortunately, families will continue to face sticker shock for medications and may be forced to make difficult choices until the pharmaceutical pricing system is reformed to address the increasing shift of costs directly to consumer," Bresch said in a statement. "Pharmaceutical pricing is too far removed from the patient at the pharmacy counter and not designed for today's increasingly consumerized health care system."
Meanwhile, Mylan’s EpiPen knockoff may not be the only rival to the pricey branded drug for long. Compounding pharmacy Imprimis, which developed a $1-per-day alternative to Turing’s notoriously price-hiked Daraprim (pyrimethamine), said it’s working on another solution, and former EpiPen competitor Auvi-Q (epinephrine autoinjector, Kaleo, Inc.)—pulled from the market after manufacturing issues spurred a hefty recall—could soon be back on the market.
Impax Labs, maker of its own approved epinephrine autoinjector, Adrenaclick, is working on significantly expanding its manufacturing capacity, too.
Source: FiercePharma; December 16, 2016.