Similar biological medicinal products containing recombinant erythropoietins - Scientific guideline

This document lays down lays down the non-clinical and clinical requirements for recombinant human erythropoietin (epoetin)-containing medicinal products claiming to be similar to another one already marketed.

Keywords: Erythropoietin, epoetin, recombinant biological medicinal products, indication, efficacy, safety, comparability, extrapolation

Current effective version

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/301636/2008 Rev. 1 Legal effective date: 01/01/2019

Document history

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)

Adopted Reference Number: EMEA/CHMP/BMWP/301636/2008

Overview of comments received on draft guideline on similar biological medicinal products containing recombinant erythropoietins

Reference Number: EMA/38050/2011

Draft guideline on non-clinical and clinical development of similar Biological medicinal products containing recombinant Erythropoietins (Revision)

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/301636/2008

Concept paper on the revision of the guidance on similar biological medicinal products containing recombinant Erythropoietins

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/170734/2008

Submission of comments on Guideline on Similar Biological Medicinal Products containing biotechnology derived products as active substance: non-clinical and clinical issues Annex: recombinant Erythropoietin containing p...

Reference Number: EMEA/CHMP/BMWP/149141/2006