Biosimilar Medicine Quality, Non-clinical and Clinical Requirements

This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of Biosimilar Medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used, but these should be scientifically and technically justified. SAHPRA is committed to ensuring that all registered medicines are of the required quality, safety, and efficacy. It is important that applicants adhere to all the administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from the Office of the Chief Executive Officer and on the SAHPRA website.