title: Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance.
abstract: Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved in the United States in March 2015 for all of the reference product's indications except acute radiation syndrome. Biosimilar G-CSFs have been largely embraced by the medical community, except for some reservations about healthy-donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community.
  
  
  
  In a two-center safety surveillance study (National Clinical Trial NCT01766934), 245 healthy volunteer stem cell donors were enrolled. Of 244 donors who began mobilization with twice-daily Sandoz biosimilar filgrastim, 242 received a full (n = 241) or partial (n = 1) course of G-CSF and underwent apheresis. Efficacy and safety were assessed and are reported here.
  
  
  
  Biosimilar filgrastim was accompanied by the typical G-CSF class-related adverse effects of expected frequency and severity. Median mobilization for CD34-positive stem cells was 97/µL (range, 20-347/µL); after one apheresis (91%) or two aphereses (9%) from all but three donors (1.2%), cell doses in excess of the typical 4 × 106CD34-positive cells/kg of the recipient had been collected (range, 3-52 × 106/kg). Biochemical and hematologic alterations were consistent with previous reports; all had normalized by the first follow-up 1 month after mobilization. Stem cell products engrafted with typical probability and kinetics for G-CSF-mobilized stem cell products.
  
  
  
  These data support the use of biosimilar filgrastim for healthy-donor stem cell mobilization as safe and effective.
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Becker
authors.affiliation: Hexal AG, Holzkirchen, Germany.
authors.forename: Arnd
authors.initials: A
authors.lastname: Schwebig
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Brauninger
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Heike
authors.initials: H
authors.lastname: Bialleck
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Beate
authors.initials: B
authors.lastname: Luxembourg
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Miriam
authors.initials: M
authors.lastname: Schulz
authors.affiliation: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Donor Service and University Hospital Ulm, Ulm, Germany.
authors.forename: Chrysanthi
authors.initials: C
authors.lastname: Tsamadou
authors.affiliation: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Donor Service and University Hospital Ulm, Ulm, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Wiesneth
authors.affiliation: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Donor Service and University Hospital Ulm, Ulm, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Reinhardt
authors.affiliation: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Donor Service and University Hospital Ulm, Ulm, Germany.
authors.forename: Joannis
authors.initials: J
authors.lastname: Mytilineos
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Seidl
authors.affiliation: Hexal AG, Holzkirchen, Germany.
authors.forename: Sreekanth
authors.initials: S
authors.lastname: Gattu
authors.affiliation: Hexal AG, Holzkirchen, Germany.
authors.forename: Natalia
authors.initials: N
authors.lastname: Kaliakina
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Pritibha
authors.initials: P
authors.lastname: Singh
authors.affiliation: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Donor Service and University Hospital Ulm, Ulm, Germany.
authors.forename: Hubert
authors.initials: H
authors.lastname: Schrezenmeier
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
authors.forename: Erhard
authors.initials: E
authors.lastname: Seifried
authors.affiliation: Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.|Department of Medicine/Hematology, University of Washington, Seattle, Washington.
authors.forename: Halvard
authors.initials: H
authors.lastname: Bonig
mesh_terms: D018952:Antigens, CD34 / Q000032:analysis; D001781:Blood Component Removal; D062665:Epidemiological Monitoring; D000069585:Filgrastim; D006085:Graft Survival / Q000187:drug effects; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D064368:Healthy Volunteers; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods* / Q000592:standards; D006801:Humans; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D014019:Tissue Donors; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim