title: Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients.
abstract: OBJECTIVE
  Filgrastim and lenograstim are the standard granulocyte colony-stimulating factor (G-CSF) agents for peripheral blood stem cell mobilization (PBSC) in patients who undergo autologous stem cell transplantation.
  
  
  METHODS
  To assess whether biosimilars are effective, we conducted a single-center, prospective study that included 40 consecutive de novo multiple myeloma patients who received cyclophosphamide 4 g/m(2) per day plus biosimilar filgrastim G-CSF to mobilize PBSC. These patients were compared with a group of 37 patients matched for age, diagnosis, previous chemotherapy and mobilization who had been treated with originator G-CSF. The mean number of CD34+ cells/μL in the peripheral blood was 199.6 ± 207.4 in the biosimilar and 192.8 ± 154.7 in the originator group (P = 0.87). The median number of CD34+ cells/kg recipient collected was 11.5 ± 5.8 and 12.3 ± 5.3 in the biosimilar and originator groups, respectively (P = 0.51). The mobilization failure rate was 2.5% and 2.7% in the biosimilar filgrastim and originator filgrastim cohorts (P = NS), respectively.
  
  
  RESULTS
  Twenty-nine patients in the biosimilar group and 28 patients in the originator group underwent autologous transplantation. There were no statistically significant differences between the biosimilar and originator G-CSF cohorts in terms of hematopoietic recovery parameters and transplant-related toxicities.
  
  
  CONCLUSIONS
  The efficacy of biosimilar G-CSF appears to be equivalent to the reference G-CSF.
authors.affiliation: Hematology and Stem Cell Transplant Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy. Electronic address: dr.massimomartino@gmail.com.
authors.forename: Massimo
authors.initials: M
authors.lastname: Martino
authors.affiliation: Biotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano (CS), Italy.
authors.forename: Anna Grazia
authors.initials: AG
authors.lastname: Recchia
authors.affiliation: Hematology and Stem Cell Transplant Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Moscato
authors.affiliation: Hematology and Stem Cell Transplant Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Fedele
authors.affiliation: Hematology Unit, Azienda Ospedaliera Papardo, Messina, Italy.
authors.forename: Santo
authors.initials: S
authors.lastname: Neri
authors.affiliation: Haematology Unit, Azienda Ospedaliera Cosenza, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Gentile
authors.affiliation: Hematology Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Alati
authors.affiliation: Hematology Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Iolanda Donatella
authors.initials: ID
authors.lastname: Vincelli
authors.affiliation: Hematology Unit, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Piro
authors.affiliation: School and Division of Hematology, University Hospital "G. Martino", Messina, Italy.
authors.forename: Giuseppa
authors.initials: G
authors.lastname: Penna
authors.affiliation: School and Division of Hematology, University Hospital "G. Martino", Messina, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Musolino
authors.affiliation: Hematology Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ronco
authors.affiliation: Hematology Unit, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
authors.affiliation: Biotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano (CS), Italy; Haematology Unit, Azienda Ospedaliera Cosenza, Italy.
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
mesh_terms: D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000378:metabolism; D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D005260:Female; D000069585:Filgrastim / Q000494:pharmacology*; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000378:metabolism; D006801:Humans; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000494:pharmacology; D014182:Transplantation, Autologous
chemical_list: D018952:Antigens, CD34; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D000069585:Filgrastim
keywords: biosimilar G-CSF; engraftment; multiple myeloma; originator G-CSF; peripheral blood stem cell mobilization