WHO’s prequalification of Mylan’s Sofosbuvir offers new hope for 70 million people living with chronic hepatitis C worldwide.

June 13, 2017

At Mylan, we are marking World Hepatitis Day with renewed hope that people around the globe will soon have greater access to life-saving medicines for hepatitis C. 
The World Health Organization (WHO) Prequalification of Medicines program recently announced its approval of our application for Sofosbuvir Tablets, 400 mg. A directly acting antiretroviral (DAA), Sofosbuvir will be available in developing countries for treatment of hepatitis C.
Produced under license from Gilead Sciences, Sofosbuvir is the first generic version of the hepatitis C medicine to be approved under the WHO program. This prequalification means that international donors and purchasers such as UNITAID and UN agencies will be able to fund and procure the product, and that other buyers can be assured of the product’s quality, safety, and efficacy. And, for all of us at Mylan, the prequalification means that we’re succeeding in fulfilling our mission -- setting new standards in healthcare and expanding access to quality, affordable medicines for the world’s 7 billion people.
According to the WHO, more than 70 million people are living with chronic hepatitis C around the globe, and nearly 400,000 die each year from the disease. Antiviral medication, such as Mylan’s Sofosbuvir, has the potential to dramatically reduce those numbers. As Dr. Suzanne Hill, Director, Essential Medicines and Health Products at WHO, said: “This is a break-through medicine with a 95% cure.” 
Working together, Mylan colleagues are bringing hepatitis C medicines to 91 countries, including developing markets such as India, where approximately 12 million people are chronically infected with the disease. We recognize the urgent need to raise awareness and expand treatment options, while increasing access to high-quality, affordable medicines. Our goal is to ensure that patients are treated and treated early, and that we can ultimately eradicate hepatitis C. 
While a great deal of progress has been made in recent years, on World Hepatitis Day, we’re reminded that there’s still much to be done for patients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world – one person at a time, in every corner of the world. We believe access to healthcare should be a right, not a privilege.