- Mylan's much-scrutinized Epipen could soon face new competition, as two small pharmaceutical companies advance their rival products towards commercialization on the U.S. market.
- Kaleo Pharma on Thursday announced its epinephrine auto-injector, Auvi-Q, would be available by prescription nationwide beginning Feb. 14. The company emphasized that customers with commercial insurance would pay $0 in out-of-pocket costs, although the list price is reportedly $4,500.
- Specialty pharma Adamis Pharmaceuticals is also moving a rival product forward, announcing its resubmitted new drug application for approval of its epinephrine pre-filled syringe has been accepted for review by the Food and Drug Administration.
Mylan had quietly cornered the epinephrine market until criticism of its sharp price increases for EpiPen brought down intense public and Congressional scrutiny on the company. From when Mylan acquired EpiPen in 2007, the company had raised the price for a twin-pack to an eye-watering $600 from under $100.
Competitors, including Auvi-Q (then marketed by Sanofi), had dropped out of the market, leaving customers with no choice, although many did not pay full price for the drug.
Mylan has since rolled out a broader patient assistance program and launched a cheaper generic version of its own drug.
Kaleo and Adamis, though, may soon give Mylan some actual market competition, however.
"With all of the recent news regarding products in the anaphylaxis market, we believe our product, now so, more than ever, can be a part of the potential solution for patients and payors as there is an obvious need for a low-cost therapeutic alternative like our [pre-filled syringe]," said Adamis CEO Dennis J. Carlo, in a statement about the device's resubmission.
Adamis' new filing addresses the issues raised in the FDA's complete response letter issued in June 2016 which included a request for more data on usability and product stress testing. If approved, Adamis' pre-filled syringe will be distributed in the U.S. by Allergan's wholly-owned subsidiary, Watson Laboratories.
Kaleo, which regained full rights to Auvi-Q from Sanofi, will reach markets even sooner. Under the company's "AffordAbility" program, patients with commercial insurance will pay no out-of-pocket charges, and for those who have no insurance and a low household income, Auvi-Q will be free of charge. Others without commercial or government insurance would pay $360.
Yet the actual list price for the drug is reportedly $4,500, highlighting the complicated pricing mechanisms which can result in significantly greater cost for the system as a whole even if patients don't see a high price tag. Rebates and discounts could lower that price for individual payer groups.
The biotech, however, will still face some commercialization challenges due to the uncertainty caused by the previous withdrawal of the device under Sanofi.
Elsewhere, Teva is also developing a generic version of the EpiPen, but because of concerns from the FDA, this isn't likely to reach the US market until 2017, as reported by Bloomberg.