Amid the national debate over drug prices, few products have been singled out more than Mylan’s EpiPen, used for emergency treatment of severe allergic reactions. But with a Food and Drug Administration decision Thursday, the EpiPen and EpiPen Jr., the version for children, have generic competition.
The FDA said it approved the first generic version of the auto-injectors, which deliver a shot of the drug epinephrine to people experiencing anaphylaxis due to insect bites and stings, foods, medications and other causes, made by Teva Pharmaceuticals USA, a subsidiary of Israeli drugmaker Teva Pharmaceutical Industries. The agency approved Teva’s auto-injector in 0.3mg and 0.15mg strengths.
The price of the EpiPen increased from about $100 less than 10 years ago to more than $600 in 2016, drawing strong criticism from the general public and resulting in Mylan CEO Heather Bresch being called to testify before Congress in September 2016. Three months later, Mylan released an authorized generic version of the EpiPen, which carried an average wholesale cost of $300 for a two-pack. Richmond, Virginia-based Kaleo manufactures the EpiPen’s brand-name competitor, the Auvi-Q auto-injector, which it provides for free to families making less than $100,000 per year or sells for $360, while the list price for insurers is $4,500.
A spokesperson for Teva said the company was applying its full resources to the launch of its generic product in the coming months, but did not say what the generic auto-injector’s price point would be. The company previously sought approval for its generic version of the EpiPen, but the FDA rejected its application in February 2016, citing “certain major deficiencies.” The “major nature” of the FDA’s complete response letter meant that launch before 2017 would not be possible.
“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,” FDA Director Scott Gottlieb said in a statement.
With the controversy surrounding its drastic increase in price, the EpiPen has become a poster child for the issue of high drug prices, an issue that figures in the Trump administration – including Gottlieb an Health and Human Services Secretary Alex Azar – have sought to address. In May, the FDA listed several drugmakers that, generic manufacturers allege, have refused to provide samples that the latter need to develop their own versions of drugs. Meanwhile, a recent report by the nonprofit Initiative for Medicines, Access and Knowledge criticized what it called gaming of the patent system by drugmakers to thwart generic and biosimilar competition, while an expert said that trade secrets add another layer of difficulty on top of the patent system for developing biosimilars in particular.
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