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)
Table of contents
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.
Keywords: Granulocyte-colony stimulating factor (G-CSF), recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies
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Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1 (PDF/150.49 KB)
Draft: consultation closed
First published: 15/08/2018
Last updated: 15/08/2018
Consultation dates: 15/08/2018 to 15/02/2019
EMEA/CHMP/BMWP/31329/2005 -
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Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (PDF/87.17 KB)
Draft: consultation closed
First published: 27/07/2015
Last updated: 27/07/2015
Consultation dates: 27/07/2015 to 31/10/2015
EMA/CHMP/BMWP/214262/2015 -
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Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating... (PDF/88.74 KB)
Adopted
First published: 22/02/2006
Last updated: 22/02/2006
Legal effective date: 01/06/2006
EMEA/CHMP/BMWP/31329/2005