FDA approves first-ever generic EpiPen versions, courtesy of Teva

pharmafile | August 17, 2018 | News story | Medical Communications, Sales and Marketing FDA, Mylan, Teva, US, epipen, pharma 

The FDA has announced the approval of the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine auto-injectors as a treatment for anaphylactic shock, the first available since the originator product was approved over two decades ago.

The new generic versions, manufactured by Teva, have secured approval after several years of attempts by Mylan to block their progress. EpiPen has been a major money-spinner for Mylan: lack of direct competition allowed the firm to reap over $1 billion per year at the peak of the product’s success and dominate 75% of the market share for epinephrine autoinjector products.

The decision follows a long period of criticism of the price tag of Mylan’s flagship product – one that was found in 2016 to have been controversially hiked. When the firm bought the rights to the product in 2007, it cost $57 a shot; just less than a decade later, a series of covert hikes had brought that asking price up to $600 for two. Beyond complaints that this prohibited patients from accessing a life-saving medicine, criticism was also levied against CEO Heather Bresch, whose salary increased 671% over the same period.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US 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,” said FDA Commissioner Dr Scott Gottlieb in a comment on the marketing authorisation. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages. The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritise the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines.

“We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritising review of many complex generic drug applications,” he added.

Matt Fellows

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