Bioequivalence centres in Africa: current state and opportunities for growth

Bioequivalence studies are required for generic medicines to meet the same quality, safety, and efficacy standards as innovator products before receiving marketing authorisation. These studies compare the in vivo performance of a generic medicine to that of the innovator product. Two products are bioequivalent if they are pharmaceutically equivalent and have similar bioavailabilities (C_max, T_max, and AUC) after the same dose is administered under the same conditions, resulting in essentially the same effects. In Africa, enforcement of bioequivalence requirements varies, and marketing authorisation can be granted based on incomplete data. Some local manufacturers have bioequivalence requirements waived, while regional joint assessments require demonstration of bioequivalence. This article reviewed the bioequivalence landscape in Africa and found that five countries have operational bioequivalence study centres, two aspire to establish them, and one has evidence of previously conducting bioequivalence studies. A major challenge for African manufacturers is limited access to local bioequivalence centres, leading to most studies being conducted in India and the Middle East, which is cost prohibitive. This article also outlines why bioequivalence facilities in Africa are underdeveloped and recommends opportunities to catalyse the growth of bioequivalence facilities across the region. The authors recommend establishing bioequivalence facilities in academic hospitals with proven clinical trial capabilities in key African markets, developing a university-accredited bioequivalence training programme to upskill regulators and pharmaceutical manufacturers, and requiring African national medicines regulatory authorities to mandate demonstration of bioequivalence for generic medicines from all applicants, local or foreign.