caa a22 4500 445314184 CHVBK 20180317142640.0 cr unu---uuuuu 170323e20110201xx s 000 0 eng 10.1007/s11095-010-0288-2 doi (NATIONALLICENCE)springer-10.1007/s11095-010-0288-2 Quality of Original and Biosimilar Epoetin Products [Elektronische Daten] [Vera Brinks, Andrea Hawe, Abdul Basmeleh, Liliana Joachin-Rodriguez, Rob Haselberg, Govert Somsen, Wim Jiskoot, Huub Schellekens] ABSTRACT: 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. The Author(s), 2010 biosimilar nationallicence immunogenicity nationallicence protein characterization nationallicence recombinant human erythropoietin nationallicence Brinks Vera Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut Hawe Andrea Department of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut Basmeleh Abdul Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut Joachin-Rodriguez Liliana Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut Haselberg Rob Department of Biomedical Analysis Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14-16, 3584 CA, Utrecht, The Netherlands aut Somsen Govert Department of Biomedical Analysis Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14-16, 3584 CA, Utrecht, The Netherlands aut Jiskoot Wim Department of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut Schellekens Huub Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/2(2011-02-01), 386-393 0724-8741 28:2<386 2011 28 11095 https://doi.org/10.1007/s11095-010-0288-2 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0288-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Brinks Vera Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Hawe Andrea Department of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut NATIONALLICENCE 700 1- Basmeleh Abdul Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Joachin-Rodriguez Liliana Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Haselberg Rob Department of Biomedical Analysis Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14-16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Somsen Govert Department of Biomedical Analysis Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14-16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Jiskoot Wim Department of Drug Delivery Technology Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, P.O. Box9502, 2300 RA, Leiden, The Netherlands aut NATIONALLICENCE 700 1- Schellekens Huub Department of Pharmaceutics Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/2(2011-02-01), 386-393 0724-8741 28:2<386 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer