Teva Pharmaceutical Industries Ltd. has launched a limited quantity of its generic version of Mylan NV's emergency anaphylaxis drug EpiPen, but despite hopes from the U.S. Food and Drug Administration that the product would usher in a lower price for the life-saving medication, it will sell for the same price as another generic version.
The Israeli pharmaceutical company will sell its generic EpiPens for $300, according to a Nov. 27 press release. Mylan markets the brand name version of EpiPen, but also launched its own generic version in late 2016. Teva's new product will match the price of Mylan's generic, which sells for $300 per two-pack.
Canonsburg, Pa.-based Mylan came under fire in 2016 from U.S. lawmakers and others when the price of the brand name auto-injector increased six-fold. The drug has consistently been pointed to as a flash-point in the national debate around drug pricing.
Teva received approval from the U.S. FDA to produce the drug on Aug. 16, with the agency suggesting that the decision would provide consumers with a cheaper version of the device.
Mylan CEO Heather Bresch shows a package of EpiPens during a September 2016 hearing regarding drug pricing on Capitol Hill in Washington, D.C.
Source: Associated Press
"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 August. "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 in a statement Nov. 27 that the agency "cannot control commercial decisions on pricing." He continued, "We have found that having three or more generic competitors brings prices down more sharply than with only one or two generic competitors."
Several other companies offer epinephrine auto-injector products similar to the EpiPen, including Amedra Pharmaceuticals LLC's Adrenaclick and Sanofi's Auvi-Q.
The release of a limited quantity of Teva's generic also comes in the middle of an EpiPen shortage. Mylan has struggled to keep up a constant supply of the drug, which spurred the FDA to place the product on the agency's shortage list. Mylan said in August that lower volumes of drugs like the EpiPen have led to a decline in the company's U.S. revenue.
Teva said a smaller dose of the medicine and an additional supply of the larger dose will be available in 2019.