Dosing Penalty of Erythropoiesis-Stimulating Agents after Switching from Originator to Biosimilar Preparations in Stable Hemodialysis Patients
| Autor: | Gianni Carraro, Domenico Santoro, Roberto Minutolo, Domenico Russo, Patrizio Imperiali, Fulvio Fiorini, Oliviero Filiberti, Luca De Nicola, Cataldo Abaterusso, Alberto Santoboni, Carlo Mura, Maurizio Borzumati, Romano Musacchio, Stefano Sposini |
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| Přispěvatelé: | Minutolo, Roberto, Borzumati, Maurizio, Sposini, Stefano, Abaterusso, Cataldo, Carraro, Gianni, Santoboni, Alberto, Mura, Carlo, Filiberti, Oliviero, Santoro, Domenico, Musacchio, Romano, Imperiali, Patrizio, Fiorini, Fulvio, DE NICOLA, Luca, Russo, Domenico |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
030213 general clinical medicine medicine.medical_specialty medicine.medical_treatment Iron 030232 urology & nephrology 03 medical and health sciences Hemoglobins 0302 clinical medicine Renal Dialysis medicine Humans Dosing Intensive care medicine Biosimilar Pharmaceuticals Erythropoietin Aged Retrospective Studies Aged 80 and over Anemia Iron-Deficiency Dose-Response Relationship Drug business.industry Drug Substitution Biosimilar Anemia Middle Aged Recombinant Proteins Trace Elements Epoetin Alfa Nephrology Hematinics Erythropoiesis Kidney Failure Chronic Female Hemodialysis business |
| Popis: | To the Editor: The efficacy of ESA biosimilars has been tested mainly in the few studies needed for marketing authorization,1-5 whereas data from individual self-reported clinical experience are lacking. Such information, together with pharmacovigilance data, is key to obtaining reassurance regarding the safety of these products. Of note, 2 studies of efficacy when switching from originator to biosimilar in hemodialysis patients have reported a dosing penalty (ie, requiring higher doses to maintain Hb level) of 4% to 13% for HX575 (epoetin alfa; Binocrit) and 10% to 15% for SB309 (epoetin zeta; Retacrit). 4,5 Dosing penalty for biosimilars is relevant not only for cost reasons, but also when considering the significant association of higher ESA dose with adverse outcomes.6 All manufacturers recommend using the lowest effective dose for correcting anemia. |
| Databáze: | OpenAIRE |
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