Efficacy And Safety Of Biosimilar Epoetin Alpha In Treated Patients With Multiple Myeloma.

e18563 Background: The biologic drugs are pharmaceutical products derived from living organisms through biotechnology. For some of the biotech drugs patent coverage is now decayed. This has allowed other companies to produce, at lower costs, similar products called biosimilar pharmaceuticals. Among the first biosimilar products marketed there were two growth factors, epoetin alpha and filgrastim. Methods: We retrospectively analyzed 15 chemo-treated patients with Multiple Myeloma (MM) referred to UOS Diagnosi e Cura delle Discrasie Plasmacellulari e delle Amiloidosi of Sant’Andrea Hospital in Rome, who were treated with biosimilar epoetin alpha between November 2010 and November 2011. In particular, 6 males and 9 females (median age 70 years) had started therapy with subcutaneous biosimilar epoetin alpha 40,000 IU weekly for haemoglobin level below 10 g/dl. In these patients, we evaluated the Hb levels before treatment, after 4 weeks and, in those who continued therapy, after 8 weeks from the drug administration start. Results: In all cases there was a significant and steady increase of Hb values: we observed an increase of 1 g/dl after 4 weeks in 80% of patients. In 5 of 11 patients the data are not available at 8 weeks because it was observed a so quick increase in Hb values as to cause discontinuation of treatment; in 100% of the remaining patients we observed an increase ≥2 g/dl after 8 weeks. None of patients needed supportive therapy with red blood cells transfusion. Although the duration of treatment in our patients was limited, we did not observe any adverse event in the short and medium term by the administration. Conclusions: The results reported do not fall in a comparative study and our initial data are still limited, however in our analysis biosimilar epoetin alpha was effective in increasing Hb values in MM patients against lower costs. It should be emphasized that this growth factor has been used in overtreated patients with impaired bone marrow reserve. In our analysis biosimilar epoetin alpha has shown efficacy and safety data to suggest the possibility of their use in alternative to biotech generators.