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

ABSTRACT:

Background

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.

Aim

This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting.

Methods

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 out

SUBMITTER: Stoppa G 

PROVIDER: S-EPMC6061296 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature