Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (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 revision - see below

Reference number EMEA/CHMP/BMWP/31329/2005
Published 22/02/2006
Effective from 01/06/2006
Keywords Granulocyte-colony stimulating factor (G-CSF), recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies
Description This document is an annex to the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. It provides guidance for demonstration of comparability of two recombinant granulocyte colonystimulating factor-containing medicinal products.


Document history

Revision 1

In progress

PDF iconDraft guideline

 


PDF iconConcept paper

Published: 15/08/2018
Deadline for comments: 15/08/2019

 

Published: 27/07/2015

First version

Current version

PDF iconAdopted guideline

In operation: 01/06/2006–present


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