Mylan will sell a generic version of its EpiPen at half the price of the branded $600 (€525) emergency allergy shots in coming weeks, bowing to pressure after US politicians derided earlier steps last week as a mere public-relations fix.
The offer by the drugmaker, which has significant facilities across Ireland, to help patients cover out-of-pocket expenses was criticised as insufficient.
It will introduce a generic EpiPen identical to the branded product, which includes the drug itself and the handheld pen with a needle that injects the shot.
The company also plans to continue to sell the branded version.
Mylan has attracted scrutiny for increasing the treatment’s price 400% in nine years — EpiPen cost $57 for a single pen when the drugmaker bought it in 2007.
Criticism of chief executive o Heather Bresch, the daughter of Democratic Senator Joe Manchin of West Virginia, quickly intensified last week as members of the Congress called for investigations and the EpiPen became campaign fodder.
Introducing a so-called authorised generic, which doesn’t require formal approval from the Food and Drug Administration, is a fast way for Mylan to get a cheaper version out without actually cutting the branded EpiPen’s price.
“They can just do it. They don’t need approval,” said David Rosen, a lawyer at Foley and Lardner.
The move won’t block future generics from competitors such as Teva, but it can help Mylan capture some of the market share it would have lost with the introduction of a rival generic, he said.
Mylan shares, which were slightly lower yesterday, had slid 12% last week as criticism mounted.
“Ensuring access to medicine is absolutely the core of Mylan’s mission,” Ms Bresch said.
“We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public’s desire to ensure this important product be accessible to anyone who needs it.”
Mylan’s control of the market increased in the past year as competitors suffered setbacks.
In March, the Food and Drug administration identified “major deficiencies” in Teva’s application.
In October, Sanofi voluntarily recalled its Auvi-Q injector. n Bloomberg
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