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

Current effective version

Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/94528/2005 Rev. 1 Legal effective date: 01/01/2019

Document history

Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/94528/2005 Rev. 1 Legal effective date: 01/01/2019

Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues - First version

Adopted Reference Number: EMEA/CHMP/BMWP/94528/2005 Legal effective date: 01/06/2006