EMA: Nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Draft

This guideline lays down the non-clinical and clinical requirements for recombinant insulin containing products, including human insulin and insulin analogues, claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies as well as the risk management plan.