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Teva Predicts Generic Auto-Injector Release of Late 2017

AJK_TwitterSenator Amy Klobuchar

A generic product to compete with the EpiPen auto-injector could be approved in late 2017 or by early 2018, Teva Pharmaceutical Industries said during a webcast about its generic drugs on Friday.

Mylan NV, the pharmaceutical company that distributes the EpiPen, which treats life-threatening anaphylaxis, has been widely criticized in recent weeks for the high cost of its two-pen device set, which has risen an estimated 500 percent to about $600 in the United States since 2008.

Mylan said on Aug. 25 it would reduce the patient cost of EpiPens by up to $300 through a discount savings card. Several days later, Mylan announced it plans to launch a generic version at half the cost of the brand name original.

One criticism of Mylan has been that the company has no competition in the epinephrine injector marketplace other than the generic version of  Adrenaclick, which is not widely available. On Friday, Sigurdur Olafsson, Teva’s chief of generic medicines, said during the webcast that his company had requested a meeting with the Food and Drug Administration (FDA) after its auto-injector application was turned down in February.

He said Teva did not at first get a response, but after “the media attention in the last two weeks, the FDA has come back to us and we will have a meeting very, very quickly.”

Mylan said this week it expects that more than 85 percent of prescriptions to shift to its soon-to-launch generic auto-injector, potentially saving patients and the healthcare system more than $1 billion. The company made the statement in its response to a letter from Republican Senator Chuck Grassley, who was among the first politicians to question the EpiPen price surge.

Grassley replied that he appreciated receiving the information provided by Mylan, but called it an incomplete response that would not satisfy constituents upset about the EpiPen price increases.

Mylan faces considerable scrutiny over the EpiPen price controversy:

• On Sept. 6, Democratic Senators Richard Blumenthal and Amy Klobuchar asked the Federal Trade Commission to issue a subpoena to Mylan “to determine whether the company deliberately engaged in exclusionary practices to hinder its competitors and maintain its monopoly position in the market.”

• On the same day, New York Attorney General Eric Schneiderman launched an antitrust investigation into Mylan over contracts to provide stock EpiPens to schools. A statement from his office charges that Mylan Pharmaceuticals “may have inserted potentially anticompetitive terms into its EpiPen sales contracts” with local school systems to receive a discounted price on the lifesaving devices. A Mylan spokesperson has told news outlets that this requirement is no longer part of its program.

• On Aug. 30, a group of 20 Democratic senators also sent a letter to Mylan asking for details about the escalating price of the branded EpiPen auto-injectors.  The House Oversight and Reform Committee has also told Mylan to submit documents related to sales pricing and profits of the EpiPen.

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