Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

Summary

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Timeline

Start

2012-09

Primary completion

2014-05

Completion

2015-03

Publications

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
• Weir MR, Pergola PE, Agarwal R, Fink JC, Kopyt NP, Singh AK, Kumar J, Schmitt S, Schaffar G, Rudy A, McKay JP, Kanceva R. A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease. Am J Nephrol. 2017;46(5):364-370. doi: 10.1159/000481736. Epub 2017 Oct 30.

Drugs

Indications