Updated 20 August 2018

Generic EpiPen gets green light from US watchdog – unclear when available in SA

The FDA has provided some relief to EpiPen users by approving a cheaper, generic version. However, if it will be available in South Africa is unclear.

The first generic version of the EpiPen was approved by the US Food and Drug Administration, paving the way for more affordable versions of the lifesaving allergy emergency medication.

Acting CEO of the South African Health Products Regulatory Authority (SAHPRA), Portia Nkambule, told Health 24 that she is unaware of any application having been made for the generic EpiPen for South African consumers. 

Though other injectors are available, this drug, made by Teva Pharmaceuticals USA, is the first the FDA has said is the equivalent of the EpiPen. It can be automatically substituted for EpiPen in pharmacies across the United States, the Washington Post reported.

New competition in this market means that the price of epinephrine, EpiPen's active ingredient, will likely decrease over the following months and therefore making it easily available for consumers. 

With a new school season about to start, people have been reporting a shortage of EpiPens, the newspaper noted. Recently, a team of South African biomedical engineers created an EpiPen replacement called the ZiBiPen. The ZiBiPen makes use of a R200 replaceable cartridge and has a lifespan of five years, compared to the EpiPen, which can only be used once. 

"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," FDA Commissioner Dr Scott Gottlieb said in an agency news release.

Cheaper options

"This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," Gottlieb added.

The price of the drug and its launch date were not yet available, but the company's statement suggested it would not be in time for many parents who are scrambling to find EpiPens in their pharmacies now, the newspaper reported. Teva will market its generic epinephrine auto-injector in 0.3mg and 0.15mg strengths.

EpiPen, made by Mylan, injects the hormone epinephrine into the thigh to reverse potentially fatal reactions to bee stings, peanuts and other allergens.

Although the key ingredient is cheap and the EpiPen was first approved in 1987, Mylan began increasing the price of the product, from less than R1 469 for a pack of two injectors in 2007 to R8 932 for a pair now. In response to criticism over the price of its drug, EpiPen introduced its own half-priced generic in 2016, the Post reported. This price reduction came as a result of a class action lawsuit brought against the pharmaceutical company for engaging in illegal schemes to dramatically increase the price of their product. 

This article will be updated as soon as more information on the possible availability of the product is provided by the SAHPRA.

Image credit: iStock


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Dr Morris is the Principal Allergist at the Cape Town and Johannesburg Allergy Clinics with postgraduate diplomas in Allergology, Dermatology, Paediatrics and Family Medicine dealing with both adult and childhood allergies.

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