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Sandoz to launch epinephrine in early 2019 at a discount to Mylan and Teva’s generics Posted 11/01/2019

Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 [1], and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers. These can include reactions to insect bites or stings, foods, medications, latex or other causes.

With the launch of Symjepi, competition in the emergency epinephrine market is fierce. Mylan launched a generic version of its brand-name EpiPen in 2016 [2], following widespread criticism of dramatic price increases of its EpiPen; between 2007 and 2016, EpiPen prices increased by nearly 550%. Mylan’s generic version is listed at a wholesale price of US$300 per two-pack, which the company says, ‘is more than 50% lower’ than the brand-name price. Mylan faced further controversy late last year when manufacturing issues caused a global shortage in the supply of its EpiPen. This was mitigated by extending the expiration date by four months for specific lots of EpiPen that were expired or close to expiring. Amid Mylan’s supply shortages, Teva Pharmaceuticals USA (Teva) launched a generic epinephrine in November 2018. It came to market at US$300 per two-pack, matching the price of Mylan’s generic product.

In 2016, following the controversy surrounding the price increases of Mylan’s brand-name EpiPen, the US Committee on Energy and Commerce raised concerns with FDA about the lack of competition in the epinephrine auto-injector market, stating ‘We must ensure that federal law and regulation are best tailored to promote a competitive prescription drug market’.

Sandoz’s Symjepi will differentiate itself from its competitors on price, coming to market with a list price of US$250 per two-pack. This is approximately 16% lower than the price of the generic epinephrine products marketed by Mylan and Teva.

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1. GaBI Online - Generics and Biosimilars Initiative. Adamis gains FDA approval for its EpiPen rival [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Generics/News/Adamis-gains-FDA-approval-for-its-EpiPen-rival
2. GaBI Online - Generics and Biosimilars Initiative. Mylan launches generic EpiPen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Generics/News/Mylan-launches-generic-EpiPen

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