WHO Prequalifies First Generic Ingredient for Hepatitis C Medicines

The World Health Organization for the first time has prequalified a generic active pharmaceutical ingredient (API) for treating hepatitis C virus (HCV).

The ingredient, sofosbuvir, is one of a small group of key elements used in creating direct-acting antiviral drugs (DAAs).

Generic drug makers will now be able to identify a quality producer of sofosbuvir when they look to manufacture the antiviral pills, the WHO said. It named Mylan Laboratories Ltd. in Hyderabad, India, as the generic ingredient’s source.

“This should increase the availability of affordable generic medicines, thereby contributing to increased patient access,’’ the organization said when it announced its March 31 decision.

Worldwide, 130 to 150 million people have chronic HCV. The virus kills approximately 700,000 each year, according to WHO estimates.

Generic competition for HCV medications has already reduced prices for antiviral drugs in many countries. In Egypt, a 3-month course of treatment with DAAs dropped to less than $200 in 2016 from $900 in the previous year. In Pakistan, the same course today costs as little as $100, the WHO said.

DAAs began gaining prominence in 2014 when they proved to significantly enhance outcomes for patients with the liver-attacking virus. Compared to the injection-based therapies of the time, the new medicines shortened the duration of treatment, limited side effects, and delivered cure rates topping 90%.

But the drugs are expensive. While some nations have negotiated prices and benefited from generics, many high- and middle-income countries have been excluded from such arrangements. That leaves patients who need DAA therapy to fend off permanent and often lethal liver damage unable to get the required care, according to the WHO.

The HCV generics business has taken hold in India. Gilead Sciences Inc., which has patents on sofosbuvir, announced in September 2014 that it had signed nonexclusive licensing pacts with 7 India-based generics makers including Mylan Laboratories Ltd. The agreements allow these companies to manufacture sofosbuvir for distribution in 91 countries. The licensees set their own prices for the generic product they produce and pay a royalty on sales to Gilead, according to Foster City, California-based Gilead’s press release.

Gilead itself sells sofosbuvir under the brand name Sovaldi. It also sells a combination of ledipasvir/sofosbuvir as Harvoni.

The WHO’s prequalification of Mylan’s generic sofosbuvir expands the company’s dealings with the ingredient. In September 2015 Mylan Pharmaceuticals Private Ltd. launched generic sofosbuvir 400 mg tablets in India under the brand name MyHep. In January 2016, it introduced generic Harvoni tablets under MyHep LVI in the country.

The WHO, the Geneva-based agency of the United Nations that focuses on public health, has prequalified APIs for other conditions. These include human immunodeficiency virus (HIV), tuberculosis (TB) and reproductive health concerns.

The prequalification process involves 2 steps. First, the WHO determines whether the ingredient complies with its standards. Second, it evaluates the manufacturing sites to make sure they meet the organization’s requirements.

The full WHO announcement can be read here, and information about the WHO prequalification process can be seen here.

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