title: Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment.
abstract: Peripheral blood haematopoietic progenitor cell mobilization has become a standard procedure prior to autologous stem cell transplantation. Biosimilar granulocyte colony-stimulating factors (GCSF) have recently been awarded European Union (EU) licences for stem cell mobilization but data for their use in this context remain limited. The biosimilar GCSF, Ratiograstim(®) (Ratiopharm, Ulm, Germany) was granted an EU licence in September 2008 and incorporated into clinical practice in the Wessex Blood and Marrow Transplantation Programme in December 2008. Data were retrospectively collected for 154 consecutive patients undergoing peripheral blood stem cell harvest between January 2009 and December 2011 using the biosimilar GCSF. 131 consecutive patients from the preceding 3 years, who had received Neupogen(®) , were used as a control. We analysed both parameters relevant to stem cell collection and engraftment data, where patients proceeded to transplantation. We found no statistically significant difference between the two groups when comparing CD34 predictors, total number of CD34(+) stem cells collected, number of days required for collection, or for time to engraftment. This is, to our knowledge, the largest direct comparison of a biosimilar GCSF with originator GCSF for stem cell mobilization. The use of biosimilar GCSF can produce a significant cost saving, allowing investment in other areas of stem cell transplantation.
authors.affiliation: Wessex Blood and Marrow Transplantation Unit, Department of Haematology, University Hospital Southampton, Southampton, UK. amy.publicover@uhs.nhs.uk
authors.forename: Amy
authors.initials: A
authors.lastname: Publicover
authors.forename: Deborah S
authors.initials: DS
authors.lastname: Richardson
authors.forename: Andrew
authors.initials: A
authors.lastname: Davies
authors.forename: Kate S
authors.initials: KS
authors.lastname: Hill
authors.forename: Carol
authors.initials: C
authors.lastname: Hurlock
authors.forename: David
authors.initials: D
authors.lastname: Hutchins
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Jenner
authors.forename: Peter W
authors.initials: PW
authors.lastname: Johnson
authors.forename: Jane
authors.initials: J
authors.lastname: Lamb
authors.forename: Harriet
authors.initials: H
authors.lastname: Launders
authors.forename: Nikki
authors.initials: N
authors.lastname: McKeag
authors.forename: Joan
authors.initials: J
authors.lastname: Newman
authors.forename: Kim H
authors.initials: KH
authors.lastname: Orchard
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000378:metabolism; D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D005062:European Union; D005260:Female; D006085:Graft Survival / Q000187:drug effects; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D006412:Hematopoietic Stem Cells / Q000166:cytology* / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D012189:Retrospective Studies; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D018952:Antigens, CD34; D059451:Biosimilar Pharmaceuticals; D016179:Granulocyte Colony-Stimulating Factor