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Mylan to distribute both Sovaldi and Harvoni for HCV in India

Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

“Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

Mylan expects distribution for sofosbuvir to begin in 2015.

Sofosbuvir was approved to treat HCV in India in January, the first country in Asia to approve the regimen, according to the release.

The FDA approved sofosbuvir in December 2013 and approved ledipasvir/sofosbuvir in October 2014.