- Teva Pharmaceuticals gained Food and Drug Administration approval to market the first generic version of EpiPen Thursday, the latest in a series of blows to the branded product's developer, Mylan, which is struggling with shortages of epinephrine auto-injector due to manufacturing woes ahead of the new academic school year. Teva's stock jumped more than 7% following the announcement.
- FDA Commissioner Scott Gottlieb, who has pledged to tackle high drug prices through increased generic competition, says the approval is evidence that the agency's commitment to speeding complex generics to market is working. It is unclear what list price Teva plans to charge for the new generic.
- The approval is the culmination of a long path for Teva. In Febuary 2016, it received a complete response letter from FDA for its EpiPen generic that cited "certain major deficiencies," significantly delaying a product launch.
While the FDA has OK'd other epinephrine auto-injectors such as Adrenaclick and Auvi-Q, this is the first time a Mylan rival has secured an approval for an EpiPen equivalent. Notably, the agency previously cleared an authorized EpiPen generic marketed by Mylan, which allowed the company to commercialize the product without its branded packaging at a lower price.
Mylan launched its authorized generic at half the price of its branded EpiPen last year, putting significant downward pressure on company sales.
The FDA has worked to encourage competition for products like EpiPen, issuing draft guidance in January 2017 aiming to assist manufacturers submitting abbreviated new drug applications for proposed combination products. Epinephrine auto-injectors are deemed combination products because they consist of both a drug, the epinephrine, and a device, the auto-injector — making them even more difficult for copycat drugmakers to manufacture.
The agency says it works one-on-one with individual companies to "support their development of such complex products."
Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our commitment to making lower cost, safe, and effective generic alternatives available to patients. https://t.co/D2xkAYFKKQ— Scott Gottlieb, M.D. (@SGottliebFDA) August 16, 2018
The approval by the agency also comes on the heels of a jab Tuesday by Mylan's rival, Kaléo, who put out a press release promoting Auvi-Q's availability in light of EpiPen's supply constraints.
Mylan enjoyed an effective monopoly for years, increasing the price of EpiPen significantly since it acquired the product in 2007, eventually drawing the ire of Congress. CEO Heather Bresch appeared before the House Oversight & Government Reform Committee Sept. 21, 2016, where she faced a series of questions by lawmakers critiquing her role in the price increases.
The EpiPen maker also faced scrutiny from the U.S. Department of Justice. In August 2017, Mylan reached a $465 million agreement with the DOJ to resolve claims that it violated the False Claims Act by misclassifying EpiPen as a generic drug to avoid paying rebates to Medicaid.
Gottlieb says FDA is continuing to work to issue and update product-specific guidance to support the development of more complex generics.
"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," Gottlieb said in a statement.