FDA approves EpiPen generic drug

EpiPen will face competition in a generic version of the auto-injector marketed by Teva Pharmaceuticals and approved by the U.S. Food and Drug Administration on Thursday.

The FDA previously approved several epinephrine auto-injector products under new drug applications by EpiPen, Adrenaclick and Auvi-Q. In addition, authorized generic versions of EpiPen and Adrenaclick are being marketed without the brand names. 

But this is the first approved generic version of EpiPen and EpiPen Jr., the FDA said.

Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening.

Life-threatening allergies and anaphylaxis can include reactions to insect bites or stings, foods, medications, latex or other causes. People who have had an anaphylaxis episode always face the risk of another and must carry an emergency dose of epinephrine at all times, the FDA said. 

Mylan faced fierce backlash when it raised the price of a two-pack of EpiPens from about $100 to more than $600 and then brought out a generic version of the drug that cost $300.

"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," said FDA Commissioner Scott Gottlieb, MD.

The epinephrine auto-injector creates a challenge for generic development because it contains a combination of products - the  drug epinephrine and the device of an auto-injector.

The FDA said it works with individual companies to support the development of such complex products.

In this case, the FDA published three draft or final guidances since 2009. It also outlined steps for regulatory clarity in a drug competition action plan announced last year.

"We're especially committed to the development of generic copies of complex products," Gottlieb said. "These products can be hard to copy, and therefore sometimes don't face timely generic competition once patents and exclusivities are no longer a block to approval."

In May, the FDA issued two new policies to stop drug makers from blocking generics.

That month, President Donald Trump issued his blueprint to lower drug prices in part by promoting more competition through advancing biosimilars and generics. 

Physicians and insurers both supported the blueprint and addressed their concerns in a letter to Health and Human Services Secretary Alex Azar.

In August 2017, Mylan, the makers of EpiPen agreed to pay $465 million to settle allegations that it knowingly misclassified the auto-injector drug as a generic to avoid paying Medicaid rebates.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com