Similar biological medicinal products containing recombinant erythropoietins

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Current effective version

Adopted guideline

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

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2012–present


Published: 24/01/2011


Published: 23/07/2009


Published: 24/07/2008

Superseded document

Adopted guideline


Submission of comments

In operation: 01/07/2006–30/11/2012


Published: 01/03/2006


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