This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).
The non-clinical section addresses the requirements of in vitro pharmacodynamic studies and cases when there is a need for additional in vivo toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies as well as the risk management plan.