• Bolong Miao, Alina Nikolaevna Isachkina, Evgeny Viktorovich Shutov, Alexander Alekseevich Selyutin, Lyudmila Vladimirovna Kvitkova, Valery Yuryevich Shilo, Olga Nikolaevna Vetchinnikova, Ilya Vyacheslavovich Alexandrov, Dmitry Vladislavovich Perlin, Alexander Vasilievich Zuev, Igor Leonidovich Davydkin, Tatyana Pavlovna Mironova, Olga Mikhailovna Solovyova, Alexey Pavlovich Tutin, Alexey Mikhailovich Omelchenko, Kriengsak Vareesangthip, Nadezhda Georgievna Khadikova, Man Li, and Xiang Li.
• Medical Department, Shenyang Sunshine Pharmaceutical Co., Ltd., Shenyang Economy & Technology Department Zone, Shenyang, P.R.China.
• Medicine (Baltimore). 2022 Nov 25; 101 (47): e31426e31426.

BackgroundEPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO® is a biosimilar formulation of EPREX®, and making it a 1:1 dose conversion from EPREX® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration.MethodsThis study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX® to EPIAO® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX® or EPIAO®. Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO®/EPREX® in parallel groups.ResultsA total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO® or EPREX®, there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO® and EPREX® groups. Most adverse events were mild to moderate and were reverted/resolved.ConclusionEPIAO® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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