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
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Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1 (PDF/251.6 KB)
Adopted
First published: 20/07/2018
Legal effective date: 01/01/2019
EMEA/CHMP/BMWP/94528/2005 Rev. 1 -
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Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues - First version (PDF/77.68 KB)
Adopted
First published: 22/02/2006
Legal effective date: 01/06/2006
EMEA/CHMP/BMWP/94528/2005