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FDA approves first EpiPen generic amid shortages Posted 28/09/2018

The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients.

FDA Commissioner, Dr Scott Gottlieb, said that the approval was part of the FDA’s ‘longstanding commitment to advance access to lower-cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval’.

EpiPen (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.

The generic epinephrine autoinjector, which is made by Teva Pharmaceuticals USA (Teva), has been approved in 0.3 and 0.15 mg strengths.

The originator product, Mylan’s EpiPen, has been under increased scrutiny after Mylan introduced a number of dramatic price increases. The list price for a set of two of the company’s EpiPen injectors increased from US$103 in 2009 to a whopping US$608 in 2016 – an increase of 480%. These price increases have been blamed for making the devices unaffordable for a growing number of families in the US [1]. The company was also accused of underpaying US Government healthcare programmes by misclassifying EpiPen as a generic and thereby paying lower rebates. This resulted in Mylan agreeing in October 2016 to pay US$465 million to the US Department of Justice (DOJ) and other government agencies [2]. In December 2016, Mylan also launched an authorized generic version of EpiPen at a wholesale price of US$300 per two-pack. This price, the company said, ‘is more than 50% lower’ than the brand-name price [1].

FDA has also taken additional action recently to mitigate shortages of EpiPen by extending the expiration date by four months for specific lots of EpiPen that are expired or close to expiring.

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References
1.    GaBI Online - Generics and Biosimilars Initiative. Mylan launches generic EpiPen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Generics/News/Mylan-launches-generic-EpiPen
2.    GaBI Online - Generics and Biosimilars Initiative. Mylan agrees to pay fine over EpiPen rebates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Generics/News/Mylan-agrees-to-pay-fine-over-EpiPen-rebates

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Source: Teva, US FDA

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