Speakers

Mr. João Tavares Neto, M.Sc., holds a bachelor’s degree in Pharmaceutical Sciences and a master’s degree in Food Science from the Federal University of Minas Gerais, Brazil. He joined the Brazilian Health Regulatory Agency (Anvisa) in 2005. At Anvisa, he has served as Coordinator of Drug Bioequivalence, Superintendent (overseeing the departments of Food, Cosmetics, Medical Devices, and Cleaning Products), and Manager of Cosmetics and Cleaning Products.

During his tenure as Coordinator of Bioequivalence, Anvisa updated the rules for waiver and substitution of bioequivalence studies, reducing the need for human testing for synthetic drugs, and revised the regulation for validation of bioanalytical methods, aligning national requirements with the international regulatory landscape.

Since 2018, he has been working at the Office of Biological Products Evaluation (GPBIO), where he contributed to updating the requirements for biosimilar registration.

Currently, he represents Anvisa in the IPRP Working Group on Biosimilars and was recently nominated as Regulatory Chair for the ICH M18 EWG, which will develop a framework for determining the utility of comparative efficacy studies in biosimilar development programs.