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)

Current effective version

PDF iconAdopted guideline

Currently under review - see below

Reference numberEMEA/CHMP/BMWP/94528/2005
Published22/02/2006
Effective from01/06/2006
KeywordsSomatropin, recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies, indication, extrapolation
DescriptionThis 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.


Document history

Revision 1 PDF iconAdopted guideline Published: 20/07/2018
Effective from: 01/01/2019

First version

Current version

PDF iconAdopted guideline In operation: 01/04/2009 - present


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