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. 2011 Feb;28(2):386-93.
doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1.

Quality of original and biosimilar epoetin products

Vera Brinks  1 , Andrea Hawe, Abdul H H Basmeleh, Liliana Joachin-Rodriguez, Rob Haselberg, Govert W Somsen, Wim Jiskoot, Huub Schellekens
Affiliations

Quality of original and biosimilar epoetin products

Vera Brinks et al. Pharm Res. 2011 Feb.

Abstract

Purpose: To compare the quality of therapeutic erythropoietin (EPO) products, including two biosimilars, with respect to content, aggregation, isoform profile and potency.

Methods: Two original products, Eprex (epoetin alpha) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alpha) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capillary zone electrophoresis and (5) in-vivo potency.

Results: Tested EPO products differed in content, isoform composition, and potency.

Conclusion: Of the tested products, the biosimilars have the same or even better quality as the originals. Especially, the potency of originals may significantly differ from the value on the label.

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Conflict of interest statement

This research was sponsored by Roche. H.S. has given presentations during congresses sponsored by companies producing epoetin products. The research group at the Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University has received grants funded by Roche, Hospira, Organon and Merck-Serono. V.B., A.H., A.H.H.B., L.J.R., R.H., G.W.S. and W.J. declare no conflict of interest.

Figures

Fig. 1
Fig. 1
HP-SEC chromatograms of the EPO products using UV detection at 280 nm (A), fluorescence detection (Exc. 280 nm, Em. 340 nm) (B) and MALLS detection (C). Inserts show a zoom into the chromatograms.
Fig. 2
Fig. 2
SDS-PAGE gel of the four EPO products under non-reducing conditions.
Fig. 3
Fig. 3
CE-UV analysis of the four EPO products.
See this image and copyright information in PMC

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References

    1. Schellekens H. How similar do ‘biosimilars’ need to be? Nat Biotechnol. 2004;22:1357–1359. doi: 10.1038/nbt1104-1357. - DOI - PubMed
    1. Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm. 2004;3:43–7.
    1. EMEA/CHMP/94528/2005. Guideline on similar biological medicinal products. In 2005.
    1. McKoy JM, Stonecash RE, Cournoyer D, Rossert J, Nissenson AR, Raisch DW, Casadevall N, Bennett CL. Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion. 2008;48:1754–1762. doi: 10.1111/j.1537-2995.2008.01749.x. - DOI - PMC - PubMed
    1. Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia. Best Pract Res Clin Haematol. 2005;18:473–480. doi: 10.1016/j.beha.2005.01.016. - DOI - PubMed