The Food and Drug Administration on Thursday approved the first generic competitor to Mylan's EpiPen, offering allergy sufferers the possibility of a lower-cost option than the brand name drug that drew scrutiny after price hikes.
EpiPen is an auto-injector that delivers epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles in the airways and tighten blood vessels. Right now, a two-pack of EpiPen, marketed by Mylan, currently lists for $608.61.
She also said FARE hopes the pricing will make it an attractive option.The top health insurers' lobby also called Teva's announcement a good sign.
On Thursday afternoon, Mylan shares fell 0.2 percent, while those of Teva increased 6.8 percent.
Gottlieb, appointed by President Donald Trump past year, has said the administration wants to make lowering drug prices a priority, though he's said recently prices may need to be increased for certain drugs in short supply. The strategy is part of a sweeping effort by the Trump administration to bring down drug prices with more low-priced competition. It can cost as much as $600 for a package of two pens, and the pens have to be replaced periodically. 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.
"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 product against drug shortages", FDA Commissioner Scott Gottlieb said in a news release.
The newly approved generic offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen. The two rivals haven't sold almost as well as EpiPen without name recognition.
Currently, EpiPens can be in short supply, with spot shortages continuing after FDA investigators found problems previous year at a Meridian Medical Technologies plant, a Pfizer subsidiary that manufactures the autoinjectors for Mylan.
Impax is now part of Amneal Pharmaceuticals Inc.
The FDA previously rejected Teva's generic EpiPen in 2016 after citing "major deficiencies" in the proposal. "We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines". It wasn't immediately clear how the cap situation was resolved as part of Teva's approval. It acquired new patents on the device that prevented others from copying its design until 2025.