Another Epinephrine Device Approved by FDA: Could this be the Tipping Point?

By Henry Ehrlich
What number of horses to make a race?A month in the past we greeted the approval of TEVA’s entry into the epinephrine injector market with cautious enthusiasm. However we additionally query whether or not the competitors for EpiPen and Auvi-Q (and Adrenaclick, the perpetual afterthought) can be enough to drive down costs. Then we got here throughout an article that posited it takes no less than three rivals to take a significant chew out of the value tag. Thus we will welcome FDA approval of a low-dose model of Symjepi, which rounds out their product line—a high-dose model had already acquired a authorities okay, though we missed that. That might make three, or so it could seem. Sadly, this one is a pre-filled syringe as an alternative of an auto-injector and would require particular coaching to be used.
Regardless, the aggressive results these new injectors symbolize are completely notional for now since they’re nowhere close to the market. A time of scarcity will not be conducive to a worth struggle. EpiPen, for generations the dominant participant, is affected by manufacturing issues and briefly provide.
For the long-term, assuming EpiPen finds its footing once more, we should surprise what number of rivals there can be and whether or not that be sufficient to strain Mylan. A lot as we love Auvi-Q it’s not a generic and should compete on the premise of coolness, ease of use, and vocal functionality. Adrenaclick, like EpiPen, is manufactured by Pfizer, and like it’s affected by manufacturing issues which have led to shortages. So can we rely it as one of many three rivals?
Ideas on Shortages
The shortages are creating some fascinating lodging. For instance, Walgreens has began providing Auvi-Q, the primary time it has been supplied at a retail pharmacy, as an alternative of by mail.
Additionally, EpiPen has relaxed its 12-month substitute coverage with the blessing of the FDA, extending it to 16 months. They’re in impact admitting that the stricter commonplace was bogus. If it stays in place, as an alternative of shopping for 10 injectors over a decade, the buyer would purchase solely about eight. That can be an enormous blow to the underside line.
And as a reminder,  the listing of Chinese language imports topic to tariffs included epinephrine the final time we appeared. If there have been a sudden rush to construct strategic epinephrine manufacturing services the fee to customers would skyrocket.
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