Regulatory Approach To Biosimilars In Africa

Smart Regulation Through Strategic Collaboration and Evidence-Based Policies

ABSTRACT

This white paper outlines a strategic approach for the African Medicines Agency (AMA) to develop regulations that make lifesaving biosimilars more accessible in Africa. There is a critical need for strategic collaboration, particularly with international partners, to reduce the high costs and long timelines that currently hinder biosimilar development. With smart regulatory reform, Africa can expand access to these critical therapies and transform healthcare delivery across the continent.