Dosing Penalty of Erythropoiesis-Stimulating Agents After Switching From Originator to Biosimilar Preparations in Stable Hemodialysis Patients

摘要

To the Editor:udThe efficacy of ESA biosimilars has been tested mainly inudthe few studies needed for marketing authorization,1-5 whereasuddata from individual self-reported clinical experience areudlacking. Such information, together with pharmacovigilanceuddata, is key to obtaining reassurance regarding the safety ofudthese products. Of note, 2 studies of efficacy when switchingudfrom originator to biosimilar in hemodialysis patients haveudreported a dosing penalty (ie, requiring higher doses toudmaintain Hb level) of 4% to 13% for HX575 (epoetin alfa;udBinocrit) and 10% to 15% for SB309 (epoetin zeta; Retacrit).ud4,5 Dosing penalty for biosimilars is relevant not only forudcost reasons, but also when considering the significant associationudof higher ESA dose with adverse outcomes.6 Alludmanufacturers recommend using the lowest effective dose forudcorrecting anemia.