Regulatory requirements for the development and registration of biosimilars in South Africa

Abstract

In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this Act. A guideline which outlines the quality, non-clinical and clinical requirements for the registration of a biosimilar medicine was first published in March 2012. This guideline was amended in August 2014 to include requirements for registering monoclonal antibody biosimilars.