Mylan launches generic hepatitis C drug in India
Hyderabad: Mylan NV on Thursday said its subsidiary, Mylan Pharmaceuticals Pvt. Ltd, has launched a generic version of US-based Gilead Sciences Inc.’s hepatitis C drug Harvoni in the Indian market.
Harvoni, a fixed-dose combination of ledipasvir-sofosbuvir of 90mg and 400mg, respectively, is an improved version of Gilead’s hepatitis C drug Sovaldi or sofosbuvir. Mylan will sell the generic version of Harvoni under the brand name MyHep LVIR.
Harvoni, approved by the US Food and Drug Administration for treatment of chronic hepatitis C genotype-1 infection, has been shown to have high cure rates of around 90%. The cost of a 12-week course of Harvoni in the US is $94,500 (Rs.63 lakh).
Mylan didn’t disclose the price of the generic version.
Mylan said it entered into a licensing and technology transfer agreement with Gilead in September 2014, granting it non-exclusive rights to manufacture and distribute generic sofosbuvir and ledipasvir-sofosbuvir tablets in 101 developing countries, including India.
Mylan is also the exclusive distributor of Gilead’s branded Sovaldi and Harvoni tablets in India.
“MyHep LVIR is an important addition to our growing hepato care segment in India and gives us the opportunity to offer patients the potential to be cured through a transformative and simplified single tablet, once-daily treatment regimen,” said Rajiv Malik, president, Mylan.