Mylan, Natco take early lead with enhanced safety profile generic drug for Hepatitis B

Two companies, one a global major, Mylan and the other, Hyderabad-headquartered niche pharma product-maker Natco Pharma, have taken an early lead in launching generic version of Tenofovir Alafenamide, TAF, 25 mg, a once-daily tablet for the treatment of chronic hepatitis B in adults.  On December 7th, Mylan launched 'HepBest', which it called, "the first drug approved in eight years for management of chronic Hepatitis B infection in India." The launch was done by Mylan Pharmaceuticals in India. Just over 10 days later, on December 18th, Natco Pharma informed the bourses on Monday that it was launching the drug  under its brand 'TAFNAT,' in India. The drug TAF, it says, demonstrates comparable efficacy, with an enhanced renal and bone safety profile as compared to earlier formulation of tenofovir (tenofovir disoproxil fumarate).

TAFNAT is manufactured under license from Medicines Patent Pool (MPP) and Gilead Sciences. Natco priced its generic medicine of TAFNAT at an MRP of INR 1900/- for a monthly pack of 30 tablets for the India market. According to Dr Jyoti Joshi, head, South Asia at the Center for Disease Dynamics, Economics and Policy, based in New Delhi, "generic drugs such as these open doors for access to medications for poor patients such as tribals in India and perhaps may also encourage the government to take it forward in its public health programme for targeted treatments."

Mylan, off course in its media release, referred to the dimension of the problem. It says, according to World Health Organization (WHO) estimates, more than 2 billion people worldwide are infected with the hepatitis B virus (HBV), of which more than 240 million have chronic liver infection. These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer. The company also quotes, Rakesh Bamzai, its President, India and Emerging Markets, as saying, "India has an estimated 40 million HBV carriers, of which 15 per cent to 25 per cent could go on to suffer from cirrhosis and liver cancer." In 2014, Mylan signed an agreement with Gilead to enhance access to TAF-based HIV treatments in developing countries. As part of the licensing agreement, on US Food and Drug Administration (FDA) approval, Mylan received a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF.