Background
Biosimilar 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 now approved for use in Europe, including a biosimilar epoetin alfa (HX757) [2].

Aims
The aim of this study was to verify that biosimilar epoetin alfa (HX575) is similar in terms of efficacy, safety and cost to originator epoetin alfa for the treatment of refractory anaemia in patients with myelodysplastic syndrome (MDS).

Methods
This was a two-centre, non-randomized, retrospective study. Between July 2008 and June 2012, 92 patients with MDS and affected by refractory anaemia were studied. Patients with 5q-syndrome were excluded from the study. Patients received either originator (group A, n = 46) or biosimilar (group B, n = 46) epoetin alfa 40,000 IU weekly by subcutaneous (SC) administration. In addition, all patients received liposomal iron (2 x 30 mg tablets orally/day), calcium levofolinate (7.5 mg/day orally) and vitamin B12 (400 mg/day orally). Epoetin treatment was discontinued if haemoglobin (Hb) level reached 12 g/dL; treatment was restarted at the same dose and schedule if Hb decreased by 1 g/dL or more. Median follow-up was 22 months (range 3–34 months). In addition to assessments of efficacy and safety, median monthly overall costs (including drug costs, transfusion costs, costs of disposable items and nursing/medical work costs) were calculated for each group.

Results
Median Hb levels at the start of the study were 8.5 g/dL in group A and 9.2 g/dL in group B. Hb level increased by 1 g/dL after a median time of 5 weeks (range 4–9) in group A and of 4 weeks (range 3–8) in group B. In group A, a Hb level >12 g/dL was achieved after a median of 12 weeks (range 4–18); in group B, a Hb level >12 g/dL was achieved after a median of 10.5 weeks (range 3–16). In group A, maintenance dose was administered with a median of every two weeks (range 2–4), while in group B maintenance dose was administered with a median of every three weeks (range 2–5). No relevant side effects were observed in either group. The median monthly cost of epoetin therapy was Euros/month1,536 (range 1,240–1,850) in group A and Euros/month 1,354 (range 954–1,550) in group B. Five patients needed transfusion support in group A and seven patients needed transfusion support in group B.

Conclusion
Biosimilar epoetin alfa (with concomitant liposomal iron, vitamin B12 and folate) appears to be similar to originator epoetin alfa in terms of efficacy and safety for the treatment of patients with MDS affected by refractory anaemia. Biosimilar epoetin alfa may also be associated with reduced overall cost of treatment. These findings require confirmation in a larger, prospective study.

Conflict of Interest
The authors of the research paper [1] did not provide the conflict of interest statement.

Abstracted by Giulio Giordano, General Medicine and Hematology Regional Hospital ‘A. Cardarelli’, Molise, Italy.

Editor’s comment
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References
1.   Giordano G, Mondello P, Tambaro R, et al. Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: a retrospective real-life approach. Mol Clin Oncol. 2015;3(4):781-4.
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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