The US Food and Drug Administration approved EpiPen's first direct-use competitor on Thursday, laying the groundwork for cheaper competition that could lower prices.
The new universal product will not carry the EpiPen name and will be manufactured by the Israeli general manufacturer Teva Pharmaceuticals. It was approved after the FDA issued a new guide to a generic copy of products such as EpiPen, which combines drugs with specialized devices to provide rapid delivery of life-threatening allergic reactions.
"This approval means that patients with severe allergies who need to continue to receive life-saving adrenaline should choose a lower cost option and another approved product to help prevent potential drug shortages," FDA Commissioner Scott Dr. Gottlieb said in a statement.
The US Food and Drug Administration said that the replacement for EpiPen sold by Mylan already exists, and Mylan also sells a "authorized" generic copy of the product. It's just an unbranded version of EpiPen.
Alternatives include Adrenaclick and Auvi-Q, the Adrenaclick manufacturer offers a cheaper, universal version of the pen. But their design is slightly different and is not an authorized copy of EpiPen.
“These products are difficult to replicate, so once patents and proprietary rights are no longer an obstacle to approval, sometimes they do not face timely imitation competition,” Gottlieb added.
Mylan, which bought EpiPen rights from another pharmaceutical company, Pfizer, has increasingly called for the price of EpiPen to rise above $600. It offers a universal version from $150 to $350.
All syringe devices provide adrenaline, which reduces swelling in the airways and increases blood flow in the veins when people suffer from allergic reactions, a life-threatening allergic reaction to food, insect bites or drugs.
According to the FDA, Teva Pharmaceuticals can sell its universal adrenaline autoinjectors at doses of 0.3 mg and 0.15 mg.
These devices provide immediate adrenaline to the thighs.
The US Food and Drug Administration says allergic reactions occur in about every 50 Americans.
“People with allergic reactions are always at risk to another person. Because of this risk, they must always carry an emergency dose of adrenaline. Many people must take multiple doses at hand.”
The first universal version of the most widely used adrenaline autoinjector approved today is part of our commitment to providing patients with a low cost, safe and effective universal alternative.
Teva did not disclose how much it would charge for generic products or when it would be available.
The company said in a statement: "We will use this important fund for this important release in the coming months and are eager to start supplying the market."
The US Food and Drug Administration said there is no serious shortage of EpiPens and similar products, but there may be occasional spot shortages. Demand usually rises at the beginning of the school year.
