title: Biosimilar Filgrastim in Autologous Peripheral Blood Hematopoietic Stem Cell Mobilization and Post-Transplant Hematologic Recovery.
abstract: To date, two kinds of Granulocyte Colony-Stimulating Factors (G-CSF) have been approved for autologous peripheral blood hematopoietic stem cell (PBSCs) mobilization and posttransplant hematologic recovery after high-dose chemotherapy: filgrastim (originator and biosimilar) and lenograstim. Biosimilar filgrastim has been approved on the basis of comparable efficacy and safety in clinical studies where it has been used as chemotherapy-induced febrile neutropenia prophylaxis, but no specific pre-registration studies have been published in the transplant setting. Hence, there is still general skepticism about the role of biosimilar G-CSFs in this setting of patients. This review of biochemical, pre-clinical and clinical data suggests significant comparability of biosimilar filgrastim with both originator filgrastim and lenograstim in autologous PBSCs mobilization and post-autograft hematologic recovery.
authors.affiliation: Hematology and Stem Cell Transplant Unit Regina Elena National Cancer Institute Via Elio Chianesi 53 - 00144 Rome, Italy. marchesi.francesco@tiscali.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Marchesi
authors.forename: Andrea
authors.initials: A
authors.lastname: Mengarelli
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000069585:Filgrastim / Q000493:pharmacokinetics / Q000627:therapeutic use; D016179:Granulocyte Colony-Stimulating Factor / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D006207:Half-Life; D006402:Hematologic Diseases / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation; D006412:Hematopoietic Stem Cells / Q000166:cytology; D006801:Humans; D000078224:Lenograstim; D011994:Recombinant Proteins / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D014182:Transplantation, Autologous
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D000069585:Filgrastim