Efficacy and safety of a biogeneric recombinant human erythropoietin in the management of chemotherapy-induced anemia: a randomized double-blind active-comparator trial

Anemia is a common complication of chemotherapy, and its presence affects the quality of life of cancer patients. Recombinant human erythropitein (rHuEPO) is the mainstay of treatment in patients suffering from chemotherapy-induced anemia. Since rHuEPO is a costly treatment, development of biogeneric products with equivalent efficacy and safety is an essential requirement. This study aimed to compare the efficacy and safety of a biogeneric rHuEPO (Epolyrec®) with those of the original brand-name product (Eprex®). Seventy-seven cancer patients with hemoglobin levels <11 g/dL, serum ferritin >100 ng/dL, and a life expectancy of at least 6 months were recruited into the trial. Included subjects were randomly assigned to either Epolyrec® (n = 37) or Eprex® (n = 40) at a weekly dose of 100 IU/kg (divided in three doses), for a period of 8 weeks. Hemoglobin and hematocrit levels were significantly increased by week 4 in the Epolyrec® group (p < 0.001), while remained statistically constant from weeks 4 to 8. In the Eprex® group, increases in hemoglobin levels did not reach significance by week 4, but the values at week 8 were significantly increased (p = 0.001). In spite of increase, no significant change in hematocrit values was observed in the Eprex® group. Comparison of the magnitude of changes in hemoglobin concentrations between the study groups revealed a significantly greater increase from baseline to week 4 in the Epolyrec® group (p = 0.02), while the change from week 4 to week 8 was greater in the Eprex® group (p = 0.005). As to hematocrit values, the magnitude of changes at both study periods was comparable between the study groups (p > 0.05). There was no report of severe adverse events in either of the study groups. The present findings support equivalent efficacy and safety of Epolyrec® and Eprex® in the management of chemotherapy-induced anemia.