Adamis gains FDA approval for its EpiPen rival

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Adamis gains FDA approval for its EpiPen rival

Generics/News | Posted 25/08/2017 0 Post your comment

Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.

US specialty pharmaceuticals firm Adamis received FDA approval for 0.3 mg pre-filled single dose syringes (PFS) for the emergency treatment of allergic reactions, under the trade name of Symjepi. The approved package will include two single dose syringes of epinephrine, used to treat anaphylactic reactions, and rivals Mylan’s renowned EpiPen.

After receiving the approval, President of Adamis Dr Dennis J Carlo said the company is already busy preparing their second new drug application, for a cheaper version of the product. He added: ‘This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices. With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market.’

Dr Carlo said the company is currently exploring options for commercialization of the product: ‘We are […] in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset.’

Mylan has previously come under fire over its pricing strategy for the branded EpiPen, after doubling the price for a pair to around US$600. Although the company launched a generic version at the end of 2016, which is available for US$300 [1], Adamis’ Symjepi could be a fierce rival.

Adamis has not yet revealed the price, but media reports suggest it could be available for as little as US$225. A spokesman for the company told Reuters that they ‘plan to position the product as a lower cost alternative’. The company is currently building stock levels in preparation for a launch in the second half of 2017.

Mylan has owned the market for emergency epinephrine for years, but this looks set to change with a growing number of competitors now entering the market. Impax Laboratories is also selling a rival ‘Adrenaclick’ device for around US$110 a pair, while private firm Kaleo Pharma also began selling its ‘Auvi-Q’ epinephrine auto-injector earlier this year.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Mylan launches generic EpiPen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Generics/News/Mylan-launches-generic-EpiPen

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Source: Adamis