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
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.