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)

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

Current effective version

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...

Adopted Reference Number: EMEA/CHMP/BMWP/31329/2005 Legal effective date: 01/06/2006

Document history

Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1

Draft: consultation closed Consultation dates: 15/08/2018 to 15/02/2019 Reference Number: EMEA/CHMP/BMWP/31329/2005 Summary:

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

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

Draft: consultation closed Consultation dates: 27/07/2015 to 31/10/2015 Reference Number: EMA/CHMP/BMWP/214262/2015 Summary:

The current guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) provides recommendations for the non-clinical and clinical development of recombinant G-CSF claimed to be similar to a reference product already authorised in the European Union (EU). This guideline was one of the first product-class specific biosimilarity guidelines and came into effect in February 2006. Since then, several biosimilar filgrastims have been licensed in the EU. It is proposed that the guideline should be updated based on the experience gained with marketing-authorisation applications and scientific advices on biosimilar filgrastims.

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...

Adopted Reference Number: EMEA/CHMP/BMWP/31329/2005 Legal effective date: 01/06/2006