Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Giovanna StoppaESAVIEW Study Group

Abstract

Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. A prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015. The study population included patients aged ≥ 18 years undergoing hemodialysis and treated with epoetins as per the clinical practice of the participating centers. The two comparison cohorts included patients treated with either an originator or a biosimilar epoetin alfa. Each patient was followed up until occurrence of any safety outcome of interest (grouped into three major categories), switch to a different ESA product, transplant or peritoneal dialysis, death, or end of the study period, whichever came first. Overall, 867 subjects were included in the study (originator: N = 423; biosimilar: N = 444). Biosimilar users were older than originator users (median age of 76 vs 64 years, respectively), more frequently affected by arrhythmia (29.3 vs 22.5%), and less frequently candidates for transplantation (3.8 vs 18.2%...Continue Reading

References

Jan 23, 2008·Current Medical Research and Opinion·Volker WizemannUNKNOWN Epoetin Zeta Study Group
Jan 9, 2010·European Journal of Clinical Investigation·UNKNOWN Italian Medicines Agency (AIFA) Research & Development Working Group
Jun 29, 2013·Expert Opinion on Biological Therapy·Luca PaniRenato Bertini Malgarini
Sep 11, 2014·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·P Minor

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Citations

Jun 23, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Valeria BelleudiUNKNOWN Italian Biosimilar Network (ItaBioNet)
Jun 12, 2020·Pharmacology Research & Perspectives·Abduzhappar GaipovMohamad Aljofan
Aug 17, 2021·Annals of Hematology·Alexander D KulaginDmitry A Kudlay

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