Quality of original and biosimilar epoetin products.
OBJECTIVE
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.


CONCLUSIONS
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.
Brinks
Vera
V
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands. v.brinks@uu.nl
Hawe
Andrea
A
Basmeleh
Abdul H H
AH
Joachin-Rodriguez
Liliana
L
Haselberg
Rob
R
Somsen
Govert W
GW
Jiskoot
Wim
W
Schellekens
Huub
H
D000818:Animals; D001688:Biological Products / Q000737:chemistry* / Q000627:therapeutic use; D002850:Chromatography, Gel; D019075:Electrophoresis, Capillary; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D004921:Erythropoietin / Q000737:chemistry* / Q000276:immunology / Q000627:therapeutic use; D051379:Mice; D020033:Protein Isoforms / Q000737:chemistry; D011994:Recombinant Proteins; D013810:Therapeutic Equivalency
D001688:Biological Products; D020033:Protein Isoforms; D011994:Recombinant Proteins; D004921:Erythropoietin