Federal regulators on Thursday approved the country’s first direct generic competitor to the EpiPen, a move that could lead the way to lower costs for the medical device.
The Food and Drug Administration (FDA) approved generic versions of both the EpiPen and the lower dose EpiPen Jr. from Teva Pharmaceuticals. They are the first generic versions of the drug that are able to be substituted for the brand name at the pharmacy counter.
“Today’s approval ... is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives,” FDA Commissioner Scott Gottlieb said in a statement.
“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” Gottlieb said.
The EpiPen is meant to inject epinephrine into patients to stop a potentially fatal allergic reaction. Consumers and lawmakers have been clamoring for a generic version of the EpiPen ever since its manufacturer, Mylan, drastically hiked the price more than 400 percent in less than a decade.
The price has risen from less than $100 in 2007 for a pack of two injectors to just over $600.
Lawmakers have often cited the price hike as a key example of skyrocketing drug costs, and CEO Heather Bresch was grilled for hours during a 2016 Senate hearing.
The company has faced little competition from other manufacturers and has benefited from a virtual monopoly on the market, partly because of the difficulty of getting a so-called combination product approved.
Combination products, such as epinephrine auto-injectors that include both a drug and a device, are "more challenging than typical drug products" to develop generic versions, the FDA said.
Mylan has also been facing supply issues. The FDA earlier this year announced a shortage of EpiPens.
Mylan introduced its own authorized generic form of the EpiPen in late 2016 after the pricing controversy. The drug is identical to the original EpiPen but without the brand name and costs $300 for a two-pack, half the price of the branded version.
Teva did not respond to questions about how much its generic version will cost, or when it will become available.
“We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva said in a statement.