Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Scientific guideline

This document 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).

Keywords: Recombinant human insulin, insulin analogues, similar biological medicinal products, biosimilar, comparability, non-clinical studies, clinical studies, hyperinsulinaemic euglycaemic clamp, glucose clamp