Natco and Mylan launches generic drug for Hepatitis B

Mylan and Natco have taken an early lead in launching a generic version of Tenofovir Alafenamide, TAF, 25 mg, and a once-daily tablet for the treatment of chronic hepatitis B in adults.

On December 7th, Mylan launched ‘HepBest’ which is called “for management of chronic Hepatitis B infection in India the first drug approved in eight years.” The launch was done by Mylan Pharmaceuticals in India.

A little more than 10 days after the fact, 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, shows similar efficacy, with an improved renal and bone safety profile when compared with before formulation of (tenofovir disoproxil fumarate). From Medicines Patent Pool (MPP) and Gilead Sciences TAFNAT is manufactured under the license.

Natco priced its generic drug of TAFNAT at an MRP of INR 1900/ – for a monthly pack of 30 tablets for the India market.

As indicated by Dr Jyoti Joshi, head, South Asia at the Center for Disease Dynamics, Economics and Policy, situated in New Delhi, “generic drugs, for example, these open doors for access to medications for poor patients such as tribals in India and may also encourage the government to take it forward in its public health program for targeted treatments.”

Mylan, of course in its media release, referred to the dimension of the issue. It says, as per World Health Organization (WHO) estimates, more than 2 billion individuals worldwide are infected with the hepatitis B infection (HBV), of which more than 240 million have a chronic liver infection.

These patients largely resulting from liver cirrhosis and liver cancer are at risk of developing serious illness and death. The company additionally quotes, Rakesh Bamzai, its President, India, and Emerging Markets, as saying, “India has an estimated 40 million HBV carriers, of which 15 percent to 25 percent could go ahead to from cirrhosis and liver cancer.”

In 2014, Mylan signed an arrangement with Gilead to improve access to TAF-based HIV treatments in developing nations. As a 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.

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