FDA approves generic competitor to EpiPens

The Food and Drug Administration approved the first direct generic competitor to the EpiPen on Thursday, setting the stage for cheaper competition that may lower prices.

The new generic, which won't carry the EpiPen name, will be made by Israeli generic manufacturer Teva Pharmaceuticals. It was approved after the FDA issued new guidance for generic copies of products like the EpiPen, which combines a drug with a specialized device to deliver it fast when people have life-threatening allergic reactions.

"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," FDA Commissioner Dr. Scott Gottlieb said in a statement.

11 PHOTOS
Mylan EpiPen price hike controversy
See Gallery
Mylan EpiPen price hike controversy
EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo GLOBAL BUSINESS WEEK AHEAD PACKAGE - SEARCH 'BUSINESS WEEK AHEAD NOV 7' FOR ALL IMAGES
Mylan NL CEO Heather Bresch testifies before a House Oversight and Government Reform Committee hearing on the Rising Price of EpiPens at the Capitol in Washington, U.S., September 21, 2016. REUTERS/Yuri Gripas
EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg
People protest outside the offices of hedge fund manager John Paulson over his fund's investment in Mylan, which manufactures EpiPens, in New York City, U.S., August 30, 2016. REUTERS/Brendan McDermid
Mylan NL CEO Heather Bresch holds EpiPens during a House Oversight and Government Reform Committee hearing on the Rising Price of EpiPens at the Capitol in Washington, U.S., September 21, 2016. REUTERS/Yuri Gripas
Lunceford Stevens holds an EpiPen during a protest outside the offices of hedge fund manager John Paulson over his fund's investment in Mylan, which manufactures EpiPens, in New York City, U.S., August 30, 2016. REUTERS/Brendan McDermid
Mylan NL CEO Heather Bresch is sworn in before a House Oversight and Government Reform Committee hearing on the Rising Price of EpiPens, at the Capitol in Washington, U.S. September 21, 2016. REUTERS/Yuri Gripas
Chairman of the House Oversight and Government Reform Committee Jason Chaffetz (R-CA) holds an EpiPen during the committee hearing on the Rising Price of EpiPens at the Capitol in Washington, U.S., September 21, 2016. REUTERS/Yuri Gripas
Mylan NL CEO Heather Bresch waits to testify before a House Oversight and Government Reform Committee hearing on Rising Price of EpiPens, at the Capitol in Washington, U.S. September 21, 2016. REUTERS/Yuri Gripas
House Oversight and Government Reform Committee ranking member Elijah Cummings (D-MD) holds an EpiPen during the committee hearing on the Rising Price of EpiPens at the Capitol in Washington, U.S., September 21, 2016. REUTERS/Yuri Gripas
Lunceford Stevens holds an EpiPen during a protest outside the offices of hedge fund manager John Paulson over his fund's investment in Mylan, which manufactures EpiPens, in New York City, U.S., August 30, 2016. REUTERS/Brendan McDermid
HIDE CAPTION
SHOW CAPTION
of
SEE ALL
BACK TO SLIDE

Alternatives to the EpiPen, sold by Mylan, already exist, and Mylan also sells a generic copy of the product. The alternatives include Adrenaclick and Auvi-Q, and the maker of Adrenaclick offers a cheaper, generic version of its injector pen. But they have slightly different designs and are not authorized copies of the EpiPen.

"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," Gottlieb added.

Mylan, which bought the rights to the EpiPen from another drug company, Pfizer, has drawn increasingly vocal outrage for hiking the price of the EpiPen to more than $600 for a twin pack. It offers the generic version for $150 to $350.

All of the injector devices deliver epinephrine, which reduces reducing swelling in the airway and increases blood flow in the veins when people are suffering anaphylaxis, a life-threatening allergic reaction to food, insect stings or medications.

"Anaphylaxis occurs in approximately one in 50 Americans," the FDA said.

"People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand."

Teva did not immediately say what it would charge for the device or when it would be available.

Read Full Story