WHO prequalifies first generic hepatitis C medicine
WHO has prequalified the first generic version of sofosbuvir, a critical medicine for the treatment of hepatitis C. The development could expand access to treatment by increasing the number of quality-assured generic medicines on the market. Sofosbuvir, 400 mg tablet, is manufactured by Mylan Laboratories Ltd., India.
WHO prequalification means the product can now be procured by the United Nations and financing agencies such as UNITAID, which now includes co-infection with HIV and hepatitis C in the portfolio of diseases it covers. Countries such as Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Kenya, Zambia, Ethiopia, Pakistan and Egypt are already procuring generic versions of sofosbuvir. The fact that WHO has prequalified one of those generics will give them extra guarantee of the product’s quality, safety and efficacy.
The average price of the required three-month treatment course of Mylan’s sofosbuvir is around US$ 260, a small fraction of the medicine’s market entry price in late 2013, and of the price set in the majority of highincome countries.