TITLE

Quality of Original and Biosimilar Epoetin Products

AUTHOR(S)
Brinks, Vera; Hawe, Andrea; Basmeleh, Abdul; Joachin-Rodriguez, Liliana; Haselberg, Rob; Somsen, Govert; Jiskoot, Wim; Schellekens, Huub
PUB. DATE
February 2011
SOURCE
Pharmaceutical Research;Feb2011, Vol. 28 Issue 2, p386
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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 alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) 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.
ACCESSION #
57495919

 

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