Quality of Original and Biosimilar Epoetin Products

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...

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Detalles Bibliográficos
Autores principales: Brinks, Vera, Hawe, Andrea, Basmeleh, Abdul H. H., Joachin-Rodriguez, Liliana, Haselberg, Rob, Somsen, Govert W., Jiskoot, Wim, Schellekens, Huub
Formato: Texto
Lenguaje:English
Publicado: Springer US 2010
Materias:
Research Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3026707/
https://www.ncbi.nlm.nih.gov/pubmed/20886265
http://dx.doi.org/10.1007/s11095-010-0288-2
Descripción
Sumario: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.

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