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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 lifesaving 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.
Alternatives to the EpiPen, sold by Mylan, already exist, and Mylan also sells an "authorized' generic copy of the product. It's simply an unbranded version of EpiPen, the FDA said.
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 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.
The approval covers generic copies of EpiPen and EpiPen Jr. for kids.
Teva Pharmaceuticals can market its generic epinephrine auto-injector in 0.3-milligram and 0.15-milligram doses, the FDA said.
The devices deliver an immediate dose of epinephrine to the thigh.
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 say how much it would charge for the generic product or when it would be available.
"We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market," the company said in a statement.
The FDA said there are no major shortages of EpiPens and similar products but there could be occasional spot shortages. Demand usually rises with the beginning of the school year.