title: 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.
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.
authors.affiliation: General Medicine and Hematology Regional Hospital 'A. Cardarelli', I-86100 Campobasso, Molise, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Giordano
authors.affiliation: Department of Oncology, G. Martino University Hospital, I-98100 Messina, Messina, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Mondello
authors.affiliation: G. Pascale Cancer Institute, I-80100 Naples, Campania, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Tambaro
authors.affiliation: Faculty of Pharmacology, G. D'Annunzio University, I-66100 Chieti, Chieti, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Perrotta
authors.affiliation: School of Medicine, University of Molise, I-86100 Campobasso, Molise, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: D'Amico
authors.affiliation: General Medicine and Hematology Regional Hospital 'A. Cardarelli', I-86100 Campobasso, Molise, Italy.
authors.forename: Antonietta
authors.initials: A
authors.lastname: D'Aveta
authors.affiliation: Family Medicine, Regional Health Service, A. Cardelli, I-86100 Campobasso, Molise, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Berardi
authors.affiliation: Services Department, Cardarelli Hospital, I-86100 Campobasso, Molise, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Carabellese
authors.affiliation: Medicine and Hematology Unit, Public Hospital, I-13900 Biella, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Patriarca
authors.affiliation: School of Medicine, University of Molise, I-86100 Campobasso, Molise, Italy.
authors.forename: Grazia Maria
authors.initials: GM
authors.lastname: Corbi
authors.affiliation: Services Department, Cardarelli Hospital, I-86100 Campobasso, Molise, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: DI Marzio
authors.affiliation: Services Department, Cardarelli Hospital, I-86100 Campobasso, Molise, Italy.
authors.forename: Antonietta
authors.initials: A
authors.lastname: Licianci
authors.affiliation: Faculty of Medicine, University 'La Sapienza', I-00185 Rome, Italy.
authors.forename: Donata
authors.initials: D
authors.lastname: Berardi
authors.affiliation: Department of Oncology, Regional Health Service, A. Cardelli, I-86100 Campobasso, Molise, Italy.
authors.forename: Liberato
authors.initials: L
authors.lastname: DI Lullo
authors.affiliation: School of Medicine, University of Molise, I-86100 Campobasso, Molise, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: DI Marco
keywords: anemia; hemoglobin; liposomal iron; myelodysplastic syndrome