Sovaldi sofosbuvir regulatory update

Hetero Drugs Ltd. (Hyderabad, India) said the Drug Controller General of India (DCGI) approved a generic version of Gilead’s Sovaldi sofosbuvir to treat HCV infection. Hetero has a non-exclusive license from Gilead as part of an agreement with 7 generic manufactures to produce and market generic versions of its HCV drugs in 91 developing countries (see BioCentury, Sept. 22, 2014). Hetero plans to launch its generic of the nucleotide analog HCV NS5B polymerase inhibitor this month as Sofovir. Sofosbuvir is dosed at 400 mg once daily. Hetero said the price for a bottle containing 28 tablets of the generic is Rs19,900 ($320.39). ...