Quality of Original and Biosimilar Epoetin Products

被引：77

作者：

Brinks, Vera ^{[1
]}

Hawe, Andrea ^{[2
]}

Basmeleh, Abdul H. H. ^{[1
]}

Joachin-Rodriguez, Liliana ^{[1
]}

Haselberg, Rob ^{[3
]}

Somsen, Govert W. ^{[3
]}

Jiskoot, Wim ^{[2
]}

Schellekens, Huub ^{[1
]}

机构：

[1] Univ Utrecht, UIPS, Dept Pharmaceut, NL-3584 CA Utrecht, Netherlands

[2] Leiden Univ, Dept Drug Delivery Technol, LACDR, NL-2300 RA Leiden, Netherlands

[3] Univ Utrecht, UIPS, Dept Biomed Anal, NL-3584 CA Utrecht, Netherlands

来源：

PHARMACEUTICAL RESEARCH | 2011年 / 28卷 / 02期

关键词：

biosimilar; immunogenicity; protein characterization; recombinant human erythropoietin; RED-CELL APLASIA; RECOMBINANT ERYTHROPOIETIN; BIOLOGICAL-ACTIVITY; GLYCOSYLATION; PROTEINS;

D O I：

10.1007/s11095-010-0288-2

中图分类号：

O6 [化学];

学科分类号：

070301 [无机化学];

摘要：

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.

引用

页码：386 / 393

页数：8

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