WHO Prequalifies First Generic Active Ingredient for Hepatitis C Medicines


For the first time, the World Health Organization (WHO) has prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd. of India.

The emergence of DAAs in 2014 gave new hope to the 80 million to 110 million people suffering from chronic hepatitis C, a disease that attacks the liver and kills approximately 700,000 people each year. The new medicines have an average 90 percent cure rate, have fewer side effects than previously available therapies and treatment regimens generally last just twelve weeks against the many months required with the older medicines. But these products are priced prohibitively, even for health systems in high-income countries.

Through a series of pricing strategies, including sub-licensing agreements, generic competition and price negotiations, some countries are making progress in tackling the disease. However, high-income and upper-middle-income countries are excluded from some of these arrangements and are often forced to ration treatment by making it available only for the sickest patients. To date, many of the people who need treatment before the virus causes permanent and often lethal liver damage are not accessing it.

By prequalifying the API, WHO has identified a quality source for generic manufacturers who wish to produce sofosbuvir. This should increase the availability of affordable generic medicines, thereby contributing to increased patient access. For example, generic competition has so far reduced prices in a number of countries: a three-month course of treatment in Egypt dropped from $900 in 2015 to less than $200 in 2016, and in Pakistan the same course today costs as little as $100.

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