Teva responds to Mylan backlash with planned launch of generic EpiPen

The Israel-based pharmaceutical company will meet with the U.S. FDA to re-submit its marketing application and hopes its version of the device will launch by 2018.
By Jessica Davis
01:46 PM
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Mylan Pharmaceutical may be getting some competition for its EpiPen, as Israel-based Teva Pharmaceutical Industries announced Friday that it hopes to launch its own generic version of the device by 2018 in the U.S.

Teva leaders plan to meet with the U.S. Food and Drug Administration soon to potentially re-submit its U.S. marketing application for its version of the device. In February, the product failed to meet FDA approval due to dosage problems, Reuters reports.

If approved during the next meeting and priced less than the EpiPen, according to Reuters, analysts predict Teva’s product could take a chunk out of Mylan’s current 94 percent market share.

[Also: EpiPen controversy fuels concerns about generic drug approval backlog]

FDA officials have contacted Teva in recent weeks, and the company had been attempting to establish this meeting since the product was rejected in February, according to Sigurdur Olafsson, Teva’s head of global generic medicines.

"We’re working with the FDA on a path forward," Olaffson said.

Currently, the company has no plans to modify the device. But according to Reuters, analysts expected Teva would modify the design of its autoinjector to address the dosage issue that originally cost the company its FDA-approval.

The announcement comes amidst growing controversy over recent price hikes that sent the cost of an EpiPen two-pack soaring from $100 to $600 this year. When the company acquired the device in 2007, it cost consumers only $57 and industry leaders say it costs about $30 to make, according to NBC.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com


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