Similar biological medicinal products containing recombinant erythropoietins - Scientific guideline
Table of contents
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
-
List item
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision) (PDF/133.13 KB)
Adopted
First published: 14/04/2010
Last updated: 07/05/2010
EMEA/CHMP/BMWP/301636/2008 -
List item
Overview of comments received on draft guideline on similar biological medicinal products containing recombinant erythropoietins (PDF/232.67 KB)
First published: 24/01/2011
Last updated: 24/01/2011
EMA/38050/2011 -
List item
Draft guideline on non-clinical and clinical development of similar Biological medicinal products containing recombinant Erythropoietins (Revision) (PDF/107.57 KB)
Draft: consultation closed
First published: 23/07/2009
Last updated: 23/07/2009
EMEA/CHMP/BMWP/301636/2008 -
List item
Concept paper on the revision of the guidance on similar biological medicinal products containing recombinant Erythropoietins (PDF/42.76 KB)
Draft: consultation closed
First published: 24/07/2008
Last updated: 24/07/2008
EMEA/CHMP/BMWP/170734/2008 -
List item
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... (PDF/245.16 KB)
First published: 01/03/2006
Last updated: 01/03/2006
EMEA/CHMP/BMWP/149141/2006