The World Health Organization has approved the first generic version of sofosbuvir, a critical drug in the treatment of hepatitis C.
This development could expand access to treatment by increasing the number of quality-assured generic medicines in the market.
Sofosbuvir, a 400mg tablet, is manufactured by Mylan Laboratories Ltd India.
“This is a breakthrough medicine with a 95-per cent cure,” Suzanne Hill, director of essential medicines and health products at WHO, said.
Treatment for hepatitis C under patent has been notoriously highly priced, putting it out of reach for many patients.
“The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product,” Dr Hill said at the 9th International Aids Conference in HIV Science in Paris.
Currently, countries such as Kenya, Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Zambia, Ethiopia, Pakistan and Egypt are already procuring generic versions of sofosbuvir.
The fact that WHO has prequalified one of the generics will give the countries extra guarantee of the product’s quality, safety and efficacy.
It is estimated that 325 million people globally are suffering from chronic hepatitis B or hepatitis C.
The WHO also estimates that about 1.3 million died from the liver-damaging disease because they did not have access to life-saving treatment.
Mylan’s sofosbuvir tablets, which are produced under licence from Gilead, are the first generic version of the direct acting antiviral to be approved under the WHO pre-qualification programme and will be available in developing countries to treat hepatitis C.