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)

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Current effective version

Adopted guideline


Currently under revision - see below

Reference numberEMEA/CHMP/BMWP/31329/2005
Published22/02/2006
Effective from01/06/2006
KeywordsGranulocyte-colony stimulating factor (G-CSF), recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies
DescriptionThis 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

Draft guideline

 


Concept paper

Published: 15/08/2018
Deadline for comments: 15/02/2019

 

Published: 27/07/2015

First version

Current version

Adopted guideline

In operation: 01/06/2006–present


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