title: A clinical comparison of the efficacy and safety of biosimilar G-CSF and originator G-CSF in haematopoietic stem cell mobilization.
abstract: BACKGROUND
  Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio(®), Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen(®), Amgen) in patients with haematological malignancies.
  
  
  METHODS
  A total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19-69). Patients had multiple myeloma (n=46), non-Hodgkin's lymphoma (n=28), Hodgkin's lymphoma (n=26), or other diagnosis (n=8). After administration of mobilizing regimens (primarily high-dose etoposide, high-dose cyclophosphamide, intermediate-dose Ara-C or ESHAP), patients were randomized to a standard daily 10 μg/kg dose of biosimilar G-CSF (n=54) or originator G-CSF (n=54).
  
  
  RESULTS
  Median duration of G-CSF administration was 8 days with both biosimilar G-CSF (range 4-17) and originator G-CSF (range 4-14). Both groups had a median of one apheresis with a median time until first apheresis of 11 days. There were no statistically significant differences between groups in the mean ± SD number of mobilized CD34+ cells/μL in peripheral blood or the number of CD34+ cells/kg body weight. Five patients (9%) in the originator G-CSF group and six patients in the biosimilar G-CSF group (11%) did not mobilize sufficient CD34+ cells. The adverse event profile was similar between groups.
  
  
  CONCLUSIONS
  A biosimilar G-CSF (Zarzio(®)) demonstrated similar efficacy and safety as the reference originator G-CSF (Neupogen(®)) in hematopoietic stem cell mobilization in patients with haematological malignancies.
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland. Electronic address: joanna_m@go2.pl.
authors.forename: Joanna
authors.initials: J
authors.lastname: Manko
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Walter-Croneck
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Jawniak
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Norbert
authors.initials: N
authors.lastname: Grzasko
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Gorska-Kosicka
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Maria
authors.initials: M
authors.lastname: Cioch
authors.affiliation: Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszynska
mesh_terms: D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000032:analysis; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000628:therapy; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor
keywords: Autologous hematopoietic stem cell transplantation; Biosimilars; G-CSF; Leukapheresis; Stem cell mobilization