Mylan Pharma launches chronic hepatitis C drug in India

Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan N V, announced on Thursday, the launch of Velpatasvir 100 mg/Sofosbuvir 400 mg tablets under the brand name MyHep All in India.

MyHep All is a fixed-dose combination tablet indicated for the treatment of chronic hepatitis C virus infection in adults, including all six major HCV genotypes. A Velpatasvir 100 mg /Sofosbuvir 400 mg combination product is currently sold by Gilead Sciences in other markets under the brand name EPCLUSA, according to the company.

HCV is a blood-borne virus commonly transmitted through unsafe injection practices, inadequate sterilisation of medical equipment, and the transfusion of unscreened blood and blood products. HCV also can be transmitted sexually and can be passed from an infected mother to her baby.

"Chronic hepatitis C is a significant public health burden in India. When we launched Mylan's Hepato Care division in January 2015, we did so to increase access to critical, life-saving medicines for patients with chronic HCV and other liver-related conditions," commented Mylan President Rajiv Malik. "The launch of the fixed-dose combination of MyHep All is part of this mission and will help patients adhere to their chronic HCV treatment regimen. Mylan has a long-standing, ongoing commitment to accelerate access and to improve treatment outcomes in India and other developing countries."

The MyHepAll launch follows Mylan's January 2016 launch of MyHep LVIR (Ledipasvir/Sofosbuvir combination) in India. Mylan has the non-exclusive right to manufacture and distribute Velpatasvir/Sofosbuvir in approximately 100 developing countries via a license agreement with Gilead Sciences.

Among other generic drug companies, Natco Pharma also launched the drug in India in May under a similar non-exclusive agreement with Gilead Sciences to manufacture and sell the generic versions of EPCLUSA.