WHO Issues Guideline For Manufacturers Of Generic Hepatitis C Medicine

The World Health Organization has issued a guidance document on the design of bioequivalence studies for a leading hepatitis C medicine. Generic drug companies seeking prequalification by the WHO need to demonstrate that their generic version is equivalent to the originator drug.

According to a WHO official, the document provides technical guidance for the prequalification process as generics companies have to do bioequivalence studies to get prequalified.

The WHO has published an updated version (March 2015) of the patent situation for sofosbuvir in about 20 countries. This update, according to the WHO, is based on data received from national and regional patent offices, including the African Regional Intellectual Property Organization (ARIPO), Brazil, the Gulf Cooperation Council, Chile, Georgia, Morocco, The Organisation Africaine de la Propriété Intellectuelle (OAPI), the Philippines, and Tunisia.