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Generic sofosbuvir and daclatasvir bioequivalent to originators Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].

Andrew Hill from the Department of Translational Medicine, University of Liverpool, UK and colleagues from across the globe contacted generics companies for results of bioequivalence studies with sofosbuvir and daclatasvir, two of the most widely used DAAs in the developing world. Data on maximum concentration (Cmax) and area under the curve (AUC) were compiled from five generics companies. Pre-specified limits for the 90% confidence intervals were 80–125% of the originator pharmacokinetic concentrations for AUC and 69–145% for Cmax.

The pharmacokinetics of generic sofosbuvir and daclatasvir were shown to be bioequivalent to the originators for all five generics companies. This is a crucial step towards securing prequalification of the manufacture of these drugs from these companies. The World Health Organization (WHO) Prequalification of Medicines Programme (PQP) ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy [2].

WHO prequalification of bioequivalent generic DAAs could then permit their export to eligible countries for mass-treatment programmes. Mass-treatment with low-cost generic HCV DAAs is the most promising method to achieve the ambitious WHO targets for HCV elimination by 2030.

Conflict of interest
The authors of the research paper [1] did not provide any conflict of interest statement.

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1. Hill A, Tahat L, Mohammed MK, et al. Bioequivalent pharmacokinetics for generic and originator hepatitis C direct-acting antivirals. J Virus Erad. 2018;4(2):128-31.
2. GaBI Online - Generics and Biosimilars Initiative. WHO prequalification programme for medicines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Policies-Legislation/WHO-prequalification-programme-for-medicines

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