WHO prequalification for generic Sovaldi

26 July 2017

Netherlands-incorporated generic drugmaker Mylan (Nasdaq: MYL) has received approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) for its application for sofosbuvir tablets, 400mg, a generic version of Gilead Sciences' (Nasdaq: GILD) Sovaldi.

Mylan's sofosbuvir tablets, which are produced under license from Gilead, are the first generic version of the direct acting antiviral to be approved under the WHO PQ Program and will be available in developing countries to treat hepatitis C.

With WHO PQ approval, international donors and purchasers, such as UNITAID and UN agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy.

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