Two years after the EpiPen price-hike scandal, the Food and Drug Administration has approved a generic competitor by Teva.
Teva’s injector is the first generic competition for Mylan’s EpiPen. Mylan introduced its own generic version of EpiPen in 2016 at half the price. Other non-generic competitors include Adamis Pharmaceuticals’ Symjepi, Impax Pharmaceuticals’ AdrenaClick, and Kaleo’s Auvi-Q.
In August 2016, Mylan came under fire for the price of EpiPen, which increased 400% over a decade. CEO Heather Bresch later defended the price because the company had invested more than $1 billion in improving the product and increasing access. Bresch later testified before Congress and the company settled a Justice Department probe for $465 million.
Last year, the FDA issued a guidance making it easier for generic companies to get drug-device combinations approved. EpiPen generics fell into that category because the injection is both a drug (epinephrine) and a device (the auto injector).
More generic approvals are part of the Trump administration’s plans to increase competition and lower drug prices.