The Food and Drug Administration accredited the first generic version of EpiPen on Thursday, a transfer that may convey new competitors for the lifesaving allergy injection that helped spark public furor over excessive drug costs.
The new drug, from Teva Pharmaceuticals USA, is the first to be deemed a therapeutic equal of the EpiPen epinephrine auto-injector, which signifies that it may be robotically substituted on the pharmacy counter for prescriptions for EpiPen or EpiPen Jr.
The approval comes proper earlier than the back-to-school season, when gross sales of EpiPen usually spike as mother and father fill up on injectors for varsity or substitute expired ones, and other people have reported problem filling EpiPen prescriptions. There has been “limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue,” in accordance with FDA spokeswoman Theresa Eisenman. Teva didn’t instantly reply to questions on how rapidly its version would turn out to be out there or what it might value.
The EpiPen, made by Mylan, is used to inject the hormone epinephrine into the thigh to quell doubtlessly deadly reactions to bee stings, peanuts and different allergens. Although the important thing ingredient is affordable and the EpiPen itself was first accredited in 1987, Mylan started growing the worth of the product, from lower than $100 in 2007 for a pack of two injectors to $608 right this moment. In response to criticism over the worth of its drug, EpiPen launched its personal half-priced generic in 2016.
Other epinephrine injectors have been accredited earlier than, however they struggled to achieve market share towards a model that used lobbying and advertising to determine a virtual monopoly available on the market. Last yr, the drug firm Sanofi accused Mylan in a lawsuit of utilizing unlawful ways to squash competitors by its injector, referred to as the Auvi-Q, which was discontinued after which relaunched by a different company, Kaléo.
Mylan in the end paid $465 million to the Justice Department over questions on whether or not the Medicaid program overpaid for the drug.
The Teva product had a tough street to approval, partly as a result of it’s a complicated generic, that means the medication contains each an injector gadget and a drug. Mylan actively fought the approval of the drug, sending a citizen petition to the FDA in 2015 arguing that the drug was not really equal. The FDA rejected Teva’s preliminary utility in 2016, citing “major deficiencies.” Under FDA Commissioner Scott Gottlieb, the company has made it a priority to clean the regulatory pathway for such “complex generics” which might be tough to repeat.
Teva’s generic will compete towards Mylan’s personal approved generic, which already has steeply eroded its brand-name gross sales. Roughly $1 billion in sales of the brand-name version of EpiPen in 2016 dropped by greater than half in 2017.
In September, the FDA stated that Meridian Medical Technologies, a Pfizer firm that manufactures the EpiPen, failed to properly investigate greater than 100 complaints that the gadget malfunctioned throughout life-threatening emergencies — together with conditions by which sufferers died.
The approval is a victory for the FDA because the Trump administration seeks to ship on its promise to lower drug prices. “This approval means sufferers residing with extreme allergy symptoms who require fixed entry to lifesaving epinephrine ought to have a lower-cost choice, in addition to one other accredited product to assist defend towards potential drug shortages,” Gottlieb stated in a press release.