While Mylan’s EpiPen has dominated the epinephrine injection market for years, two new contenders are planning to launch versions… could these help relieve shortages?
With no generic versions and few comparable alternatives, Mylan’s EpiPen has dominated the epinephrine injection device landscape for years.
Meanwhile shortages have plagued the product, with continuing issues with the supply of EpiPens in Australia and worldwide.
Two pharmaceutical companies have announced that they intend to launch contenders that they say have the “potential to completely transform the space”.
In July 2018, Adamis Pharmaceuticals and Sandoz announced that they would launch Symjepi, an epinephrine pre-filled syringe that is the first of its kind.
And in mid-August, Teva Pharmaceuticals announced that its application for a generic epinephrine auto-injector was finally approved by the FDA.
“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 said on 16 August.
“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.”
Sandoz and Teva will have the resources to enact powerful marketing strategies, drawing significant market share away from Mylan, says Rose Joachim, pharma analyst at GlobalData.
Dr Joachim says Teva’s device has the “significant advantage” of being a generic product that can be directly substituted for the EpiPen at the pharmacy level, due to a similar injection mechanism.
“The events of this summer [in ths US] are likely to really shake up the epinephrine injection device market,” she says.
“GlobalData believes that if powerful generics giants like Sandoz and Teva can navigate the space successfully, the eventual launch of their devices will continue to transform the space for the foreseeable future.”
Once the new products from Sandoz and Teva are launched internationally, they would still need to be approved and listed by the TGA before they could become available here.
Meanwhile the TGA and the Federal government are yet to find a solution to the EpiPen supply crisis in Australia.
The TGA’s latest notification in early August warned that “Alphapharm Pty Ltd (trading as Mylan Australia), has confirmed that, while supply to wholesalers is increasing, there continues to be tight supply of EpiPens”.
It has s advised that supply of EpiPen 300 mcg is “constrained due to manufacturing delays. Stock levels will not return to normal for some months”.
Supply of EpiPen Jnr 150 mcg is not affected.
Mylan has added that its dedicated EpiPen Customer Service Toll-Free hotline on 1800 931 625 is still available for pharmacies.
The company is advising pharmacies to refresh EpiPen 300 mcg Adrenaline (epinephrine) Auto-Injector orders with wholesalers on a weekly basis, as “backorders are being cancelled after any partial shipment of stock”.