Similar biological medicinal products containing recombinant erythropoietins

Current effective version PDF icon<b>Adopted guideline</b>
Reference numberEMEA/CHMP/BMWP/301636/08
Published14/04/2010
Effective from01/12/2012
KeywordsErythropoietin, epoetin, recombinant biological medicinal products, indication, efficacy, safety, comparability, extrapolation
DescriptionThis 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.


Document history

Revision 1

PDF iconAdopted guideline

Published: 23/07/2018
Effective from: 01/01/2019

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/12/2012 - present


Published: 24/01/2011


Published: 23/07/2009


Published: 24/07/2008

Superseded document

Adopted guideline


PDF iconSubmission of comments

In operation: 01/07/2006–30/11/2012


Published: 01/03/2006


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