PITTSBURGH — This week, Mylan N.V. began making an authorized generic of its EpiPen epinephrine auto-injector available to pharmacies.
Mylan said its generic epinephrine auto-injector, announced in late August, carries a wholesale acquisition cost (WAC) of $300 per two-pack carton, more than 50% lower than the WAC of EpiPen 2-Pak Auto-Injectors.
The generic EpiPen, which comes in 0.15-mg and 0.3-mg strengths, has the same drug formulation and device functionality as the branded product and is administered in the same way. The epinephrine auto-injector provides a quick, easy-to-administer treatment for anaphylaxis, or potentially life-threatening allergic reactions.
“Americans are rightfully concerned about rising drug prices, and now more than ever patients and families across this country are standing at the pharmacy counter struggling to pay for their medications,” Mylan chief executive officer Heather Bresch said in a statement. “While it is important to understand the outdated and complex system that determines what someone pays for medicine in the U.S., hardworking families don’t need an explanation, they need a solution. This is why we took decisive action with our EpiPen product and have launched the first generic version at half the WAC price.
“This unprecedented action, along with the enhancements we made to our patient access programs, will help patients and provide substantial savings to payors,” Bresch added.
Mylan said it will have a salesforce of about 275 representatives selling the generic EpiPen. To further increase access to treatment, the company has launched an additional patient purchase option at $300 per two-pack and is offering a savings card for eligible patients with commercial health insurance, providing up to $25 off the out-of-pocket cost for the authorized generic. Mylan added that it will continue to offer its patient assistance program to support uninsured and underinsured consumers.
Mylan’s announcement of a generic EpiPen came amid a public furor over a steep price hike for the product in recent years. EpiPen’s ease-of-use and reliability have made it an essential emergency treatment for anaphylaxis, and the product has been the only one of its kind available since Sanofi’s Auvi-Q was pulled from the market in 2015 due to dosing issues.
However, in late October, Auvi-Q developer Kaleo said it plans to reintroduce the Auvi-Q epinephrine auto-injector to the U.S. market in the first half of 2017. Back in February, Sanofi and Kaleo announced plans to terminate their licensing and development agreement, which returned Auvi-Q’s U.S. and Canadian rights to Kaleo and cleared the way for the company to reintroduce the product.
In late August, during the public outcry over EpiPen pricing, Impax Laboratories Inc. spotlighted its generic epinephrine auto-injector. In what Impax called an update, the company said it was providing additional information to patients, doctors and customers about its epinephrine auto-injector in 0.15-mg and 0.3-mg doses, an authorized generic of Amedra Pharmaceuticals’ Adrenaclick.