原研和生物类似物重组人促红素产品的质量。
Quality of original and biosimilar epoetin products.
机构信息
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands.
出版信息
Pharm Res. 2011 Feb;28(2):386-93. doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1.
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.
目的
比较治疗用红细胞生成素（EPO）产品的质量，包括两种生物类似药，内容物、聚集、异构体分布和效价方面。
方法
使用（1）高效体积排阻色谱法、（2）ELISA、（3）SDS-PAGE、（4）毛细管区带电泳和（5）体内效价比较两种原研产品（Eprex [epoetin alpha]和Dynepo [epoetin delta]）和两种生物类似药（Binocrit [epoetin alpha]和Retacrit [epoetin zeta]）。
结果
检测的 EPO 产品在含量、异构体组成和效价方面存在差异。
结论
在所测试的产品中，生物类似药与原研药具有相同或甚至更好的质量。特别是，原研药的效价可能与标签上的值有显著差异。
Zotero 插件