Establishing bioequivalence capacity in Kenya: Feasibility insights, strategic pathways, and regulatory imperatives

James Hungo Kimotho, Peter Mbugua Njogu, Wesley Ronoh, Felistas Chepwogen, Faith Njoki Ndung, Brayhan Kariuki Ireri, Isaac Kimani Githaiga, Technology Transfer Division, Kenya Medical Research Institute, Department of Pharmaceutical Chemistry, School of Pharmacy, University of Nairobi, Penam Consultancy Limited, Poisons Board, Ministry of Health

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Published online on December 05, 2025

Abstract

Journal of Generic Medicines, Volume 22, Issue 1, Page 41-52, March 2026.
BackgroundBioequivalence (BE) studies are crucial for ensuring generic medicines meet the same rigorous standards of quality, safety, and efficacy as their corresponding innovator brands. Since 2010, locally manufactured multisource drug products have ...