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Abstract. Several biosimilar versions of recombinant human erythropoietin are currently approved for use in Europe, including a biosimilar epoetin-α. The aim of this the study was to verify that biosimilar epoetin-α is similar in terms of efficacy, safety and cost to originator epoetin-α for the treatment of refractory anemia in patients with myelodysplastic syndrome. A total of 92 patients with myelodysplasia and refractory anemia were investigated. The patients received either originator (group A) or biosimilar (group B) epoetin-α. In addition, they received liposomal iron (Sideral ® ), calcium levofolinate and vitamin B12. Moreover, the median monthly overall costs were calculated for each group. The results demonstrated that hemoglobin (Hb) levels increased by 1 g/dl after a median time of 5 weeks in group A and 4 weeks in group B. In group A, a Hb level of >12 g/dl was achieved after 12 weeks, while in group B after 10.5 weeks. The median cost of therapy was 1,536 euros/month in group A and 1,354 euros/month in group B. A total of 5 patients required transfusion support in group A and 7 in group B. In conclusion, biosimilar epoetin-α appears to be comparable to originator epoetin-α in terms of efficacy and safety for the treatment of refractory anemia. IntroductionBiosimilar drugs are similar, but not identical, versions of biological medicines that have already been approved. 'Biosimilar' is a regulatory term used to indicate a biopharmaceutical product that has been approved under a well-defined regulatory pathway, such as the one established by the European Medicines Agency (EMA). Several biosimilar versions of recombinant human erythropoietin are currently approved for use in Europe, including a biosimilar epoetin-α (HX757). HX575 is a biosimilar version of human recombinant erythropoietin (epoetin-α) that was approved for use in Europe in 2007 under the EMA biosimilar approval pathway. HX575 was approved by the EMA in Europe after it exhibited similarity/comparability to originator epoetin-α in terms of protein structure, equivalence with respect to pharmacokinetic and pharmacodynamic profiles and comparable clinical efficacy and safety profiles in studies (1-3). Although the use of erythropoiesis-stimulating agents (ESAs) for low-risk patients with myelodysplastic syndromes (MDS) is currently supported by all major MDS treatment guidelines regarding hematopoietic growth factors (4-8), data on the use of biosimilar ESAs in this population are lacking. The aim of this study was to determine whether HX575 is similar in terms of efficacy, safety and cost to originator epoetin-α for the treatment of refractory anemia in patients with MDS.