Efficacy, safety, and immunogenicity of UB-851 versus Eprex® in patients with renal anemia receiving hemodialysis: A randomized, double-masked, phase III trial

Background: Anemia is a common complication in patients with chronic kidney disease (CKD), for which recombinant human erythropoietin (rhEPO) is the standard treatment. UB-851 is a biosimilar rhEPO developed as an alternative to epoetin alfa (Eprex ® ). This study evaluated the clinical equivalence, safety, and immunogenicity of UB-851 compared with epoetin alfa in patients with anemia due to CKD receiving hemodialysis. Methods: In this 52-week, multicenter, randomized, parallel-group, phase III trial, patients with anemic CKD undergoing maintenance hemodialysis were assigned to receive either UB-851 or epoetin alfa. Part I (weeks 1–24) included dose titration and hemoglobin (Hb) maintenance. Part II (weeks 25–52) focused on long-term safety and immunogenicity. The primary endpoint was the change in Hb levels from baseline to the efficacy evaluation period (weeks 21–24). The secondary endpoints included epoetin dose, adverse events (AEs), and anti-drug antibody formation. Results: A total of 201 participants were randomized, and the mean change in Hb levels during the efficacy period was within the predefined equivalence margin (±0.6g/dL) in both the intention-to-treat and per-protocol populations. Differences in weekly epoetin dose changes between the groups also fell within the predefined equivalence range (±45 IU/kg/week). No significant differences were observed in the laboratory parameters, electrocardiograms, or vital signs. No anti-epoetin antibodies were detected in the UB-851 group. Regarding AEs, the UB-851 appears to be biosimilar to epoetin alfa. Conclusion: UB-851 demonstrated clinical equivalence to epoetin alfa in maintaining Hb levels in patients with anemic CKD undergoing hemodialysis. The safety and immunogenicity profiles were comparable, supporting UB-851 as a biosimilar to epoetin alfa.