Similar medicinal products containing somatropin (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues) - Scientific guideline

This document is an annex to the guideline on similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues. It lays down the non-clinical and clinical requirements for somatropin-containing medicinal products claiming to be similar to another one already marketed.

Keywords: Somatropin, recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies, indication, extrapolation