April 10, 2017
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WHO prequalifies first generic active ingredient for treatment of HCV

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The WHO prequalified the generic active pharmaceutical ingredient sofosbuvir on Mar. 31, 2017, according to a press release from the organization. This is the first time WHO has prequalified a generic active ingredient for hepatitis C.

By prequalifying sofosbuvir (sold in the U.S. under the brand name Sovaldi, Gilead Sciences), WHO has identified Mylan Laboratories, India, as a quality manufacturer of this generic ingredient. According to the release, WHO believes this will improve global access to the cure for HCV.

“This should increase the availability of affordable generic medicines, thereby contributing to increased patient access,” WHO reported in their press release. “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.”

Reference: www.who.int