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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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
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author Brinks, Vera
Hawe, Andrea
Basmeleh, Abdul H. H.
Joachin-Rodriguez, Liliana
Haselberg, Rob
Somsen, Govert W.
Jiskoot, Wim
Schellekens, Huub
author_facet Brinks, Vera
Hawe, Andrea
Basmeleh, Abdul H. H.
Joachin-Rodriguez, Liliana
Haselberg, Rob
Somsen, Govert W.
Jiskoot, Wim
Schellekens, Huub
author_sort Brinks, Vera
collection PubMed
description 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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spelling pubmed-30267072011-02-22 Quality of Original and Biosimilar Epoetin Products Brinks, Vera Hawe, Andrea Basmeleh, Abdul H. H. Joachin-Rodriguez, Liliana Haselberg, Rob Somsen, Govert W. Jiskoot, Wim Schellekens, Huub Pharm Res Research Paper 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. Springer US 2010-10-01 2011 /pmc/articles/PMC3026707/ /pubmed/20886265 http://dx.doi.org/10.1007/s11095-010-0288-2 Text en © The Author(s) 2010 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Research Paper
Brinks, Vera
Hawe, Andrea
Basmeleh, Abdul H. H.
Joachin-Rodriguez, Liliana
Haselberg, Rob
Somsen, Govert W.
Jiskoot, Wim
Schellekens, Huub
Quality of Original and Biosimilar Epoetin Products
title Quality of Original and Biosimilar Epoetin Products
title_full Quality of Original and Biosimilar Epoetin Products
title_fullStr Quality of Original and Biosimilar Epoetin Products
title_full_unstemmed Quality of Original and Biosimilar Epoetin Products
title_short Quality of Original and Biosimilar Epoetin Products
title_sort quality of original and biosimilar epoetin products
topic Research Paper
url 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
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