title: Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens.
abstract: BACKGROUND
  Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.
  
  
  METHODS
  With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed.
  
  
  RESULTS
  Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim(®) and Zarzio(®) was associated with cost reductions of 56% and of 86%, respectively.
  
  
  CONCLUSIONS
  Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT.
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Bassi
authors.affiliation: Oncology Unit, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Elisa M
authors.initials: EM
authors.lastname: Stroppa
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Carlo F
authors.initials: CF
authors.lastname: Moroni
authors.affiliation: Immunohaematology and Transfusion Medicine, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Arbasi
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Trabacchi
authors.affiliation: Immunohaematology and Transfusion Medicine, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Di Franco
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Lazzaro
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Bernuzzi
authors.affiliation: Immunohaematology and Transfusion Medicine, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Moretto
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Arcari
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Costanza
authors.initials: C
authors.lastname: Bosi
authors.affiliation: Antiblastic Drugs Unit and Pharmacy, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Riva
authors.affiliation: Oncology Unit, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Cavanna
authors.affiliation: Haematology Unit and Bone Marrow Transplant Centre, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Vallisa
mesh_terms: D000328:Adult; D000368:Aged; D064592:Autografts; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D003365:Costs and Cost Analysis; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008223:Lymphoma / Q000191:economics / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000191:economics / Q000628:therapy*; D012189:Retrospective Studies; D019172:Transplantation Conditioning
chemical_list: D059451:Biosimilar Pharmaceuticals; D000069585:Filgrastim