US approves first generic competitor to Mylan’s $600 EpiPen: FDA says new Israeli version will be affordable (but did not say how much it is)
- In 2008, an EpiPen packet (which contains two) cost $100
- Mylan came under fire in 2016 for raising the price to $600
- They subsequently released a generic that costs $300 for two
- Now Israeli firm Teva is approved to release a generic; they have not said how much it will cost but the FDA said it will be affordable
US regulators have approved the first generic alternative for the EpiPen, a life-saving emergency allergy medicine – two years after uproar over soaring prices for the original version owned by Mylan.
The US Food and Drug Administration granted approval to Israel-based Teva Pharmaceuticals on Thursday to market its generic epinephrine auto-injector.
The device administers emergency treatment for allergic reactions.
Teva did not immediately say how much its product would cost or when it would be available, but FDA Commissioner Dr Scott Gottlieb insisted it will offer Americans a cheaper alternative to Mylan’s $300 generic, or the $600 original EpiPen.
Mylan Pharmaceuticals, which makes the EpiPen, faced an outpouring of criticism after it raised the price of a pack up two to $600 in 2016. The same package cost $100 in 2008
‘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 Scott Gottlieb.
Mylan Pharmaceuticals, which makes the EpiPen, faced an outpouring of criticism after it raised the price of a pack up two to $600 in 2016. The same package cost $100 in 2008.
Mylan then introduced its own generic alternative late in 2016 at a cost of $300.
Its shares rose six percent on the news.
The EpiPen is designed to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction, whether to bee stings, peanuts or other foods, medications, latex or other causes.
Anaphylaxis is ‘a medical emergency that affects the whole body and, in some cases, leads to death,’ affecting about one in 50 Americans, the FDA said.
People who have suffered from anaphylaxis once face a continual risk of another episode and must carry an emergency dose of epinephrine at all times.