WHO Issues Guideline For Manufacturers Of Generic Hepatitis C Medicine

The World Health Organization has issued a guidance document on the design of bioequivalence studies for a leading hepatitis C medicine. Generic drug companies seeking prequalification by the WHO need to demonstrate that their generic version is equivalent to the originator drug.

According to a WHO official, the document provides technical guidance for the prequalification process as generics companies have to do bioequivalence studies to get prequalified.

WHO prequalification of medicines is a service assessing the quality, safety and efficacy of medicinal products, according to WHO. At the end of 2012, WHO List of Prequalified Medicinal products contained 316 medicines for priority diseases, the fact sheet said.

“Every year, billions of US dollars worth of medicines are purchased by international procurement agencies for distribution in resource-limited countries. Prequalification is intended to give these agencies the choice of a wide range of quality medicines for bulk purchase,” according to the WHO fact sheet.

The guidance document [pdf] issued last week concerns sofosbuvir, which is protected by a Gilead Sciences patent. Sofosbuvir, commercialised under the name Sovaldi by Gilead, has been denounced by some for its high price, reaching US$1,000 per pill.

According to the WHO official, the patent was not granted in Egypt, so the generic version can be manufactured by local producers. The same applies to Bangladesh, which is a least-developed country, and does not grant patents. Several India-based generics companies also benefit from a licence from Gilead, he told Intellectual Property Watch.

On 15 September 2014, Gilead Sciences announced non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers “to expand access to its chronic hepatitis C medicines in developing countries.” The agreements allow the companies to manufacture sofosbuvir and “the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries,” according to the Gilead press release.

The WHO has carried out an analysis of the patent situation for seven new hepatitis treatments.

“These landscapes provide clarity on whether the medicines are patent protected or not in individual countries,” according to the WHO.

The WHO has published an updated version (March 2015) of the patent situation for sofosbuvir in about 20 countries. This update, according to the WHO, is based on data received from national and regional patent offices, including the African Regional Intellectual Property Organization (ARIPO), Brazil, the Gulf Cooperation Council, Chile, Georgia, Morocco, The Organisation Africaine de la Propriété Intellectuelle (OAPI), the Philippines, and Tunisia.