Quality of Original and Biosimilar Epoetin Products

V. Brinks, A. Hawe, A.H.H. Basmeleh, L. Joachin-Rodriguez, R. Haselberg, G.W. Somsen, W. Jiskoot, H. Schellekens

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Pages (from-to)386-393
Number of pages8
JournalPharmaceutical Research
Volume28
Issue number2
DOIs
Publication statusPublished - 2011

Keywords

  • Farmacie/Biofarmaceutische wetenschappen (FARM)
  • Medical technology
  • Farmacie(FARM)
  • Bescherming en bevordering van de menselijke gezondheid
  • Biomedische technologie en medicijnen
  • Public Health
  • Analytical chemistry
  • Pharmacology
  • Drugmisbruik en verslaving

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