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NDT Advance Access originally published online on February 18, 2009
Nephrology Dialysis Transplantation 2009 24(5):1366-1368; doi:10.1093/ndt/gfp058
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© The Author [2009]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Efficacy of recombinant erythropoietins: is there unity of international units?

Wolfgang Jelkmann

Institute of Physiology, University of Luebeck, Luebeck, Germany

Correspondence and offprint requests to: Wolfgang Jelkmann, Institute of Physiology, University of Luebeck, Ratzeburger Allee 160, D-23538 Luebeck, Germany. Tel: +49-451-500-4150; Fax: +49-451-500-4151; E-mail: Jelkmann@physio.uni-luebeck.de

Keywords: Biosimilars; epoetin; erythropoiesis; recombinant human erythropoietin

The first 150 words of the full text of this article appear below.

The European Medicines Evaluation Agency (EMEA) has developed guidelines to ensure similarity, ‘in terms of quality, safety and efficacy’, between similar biological medicinal products (biosimilars) in comparison to the originators (http://www.emea.eu.int). The quality and safety of biosimilar recombinant human erythropoietins (rhEPOs) has been previously discussed [1–3]. The present comment focuses on the comparability of the in vivo potency of rhEPOs, which is relevant to the economic use of erythropoiesis stimulating agents (ESAs), because biosimilar rhEPOs have been priced by up to 30% lower than the originators in some countries of the European Union (EU).



   Therapeutic rhEPOs
 
According to the International Nonproprietary Name (INN), experts of the World Health Organization (WHO), ‘epoetins’ are rhEPOs with the same amino acid sequence and glycosylation sites as endogenous EPO [4]. Amino acid changes are indicated by distinct prefixes (e.g. ‘darbepoetin’) and glycan differences by Greek letters. The composition of the glycans of . . . [Full Text of this Article]



   Definition of the EPO unit
 


   In vivo EPO bioassays
 


   Potency of follow-on epoetins
 


   Conclusions
 

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