title: Quality of original and biosimilar epoetin products.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Sorbonnelaan 14 -16, 3584 CA, Utrecht, The Netherlands. v.brinks@uu.nl
authors.forename: Vera
authors.initials: V
authors.lastname: Brinks
authors.forename: Andrea
authors.initials: A
authors.lastname: Hawe
authors.forename: Abdul H H
authors.initials: AH
authors.lastname: Basmeleh
authors.forename: Liliana
authors.initials: L
authors.lastname: Joachin-Rodriguez
authors.forename: Rob
authors.initials: R
authors.lastname: Haselberg
authors.forename: Govert W
authors.initials: GW
authors.lastname: Somsen
authors.forename: Wim
authors.initials: W
authors.lastname: Jiskoot
authors.forename: Huub
authors.initials: H
authors.lastname: Schellekens
mesh_terms: D000818:Animals; D001688:Biological Products / Q000737:chemistry* / Q000627:therapeutic use; D002850:Chromatography, Gel; D019075:Electrophoresis, Capillary; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D004921:Erythropoietin / Q000737:chemistry* / Q000276:immunology / Q000627:therapeutic use; D051379:Mice; D020033:Protein Isoforms / Q000737:chemistry; D011994:Recombinant Proteins; D013810:Therapeutic Equivalency
chemical_list: D001688:Biological Products; D020033:Protein Isoforms; D011994:Recombinant Proteins; D004921:Erythropoietin