Quality of Original and Biosimilar Epoetin Products

Publication Type:

Journal Article

Source:

Pharmaceutical Research, Volume 28, Number 2, pp. 386-393 (2011)

ISBN:

0724-8741

DOI Name (links to online publication)

10.1007/s11095-010-0288-2

Keywords:

biosimilar; immunogenicity; protein characterization; recombinant human erythropoietin; red-cell aplasia; recombinant erythropoietin; biological-activity; glycosylation; proteins

Abstract:

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

21/04/2011