title: Update on biosimilars of granulocyte colony-stimulating factor - when no news is good news.
abstract: OBJECTIVE
  With the approval of the first biosimilar granulocyte colony-stimulating factor (G-CSF), biosimilars - copies of therapeutic biologicals whose patent protection has expired - have finally reached the US healthcare market. Its advent is an occasion for a closer look at recent insights into biosimilar G-CSF and an attempt at prognosticating the future (future role) of biosimilars in general.
  
  
  RESULTS
  Recent literature regarding biosimilar G-CSF orbits significantly around patient access and effects on healthcare expenditure. The advent of biosimilar G-CSF has induced unexpectedly large price reductions for short-acting G-CSF. On the clinical side, little excitement is tangible, probably appropriately so, since clinical data indicate nothing short of biological similarity. Although formal clinical trials are few, the plethora of case series and historic comparisons which have come forth offer reassurance about the appropriateness of the regulators' assessment of biosimilar G-CSF as indeed in all respects biologically similar to the originator.
  
  
  CONCLUSIONS
  All evidence points to an overwhelming similarity of originator and biosimilar G-CSF in all indications. Overall clinical acceptance, albeit possibly significantly dictated by economic pressures, is good. Price reductions exceed predictions and may jeopardize the economic viability of biosimilar programs. A concurrent shift towards long-acting G-CSF ('biobetters') is observed in Europe.
authors.affiliation: aGerman Red Cross Blood Service Baden-Württemberg-Hesse, Frankfurt bDepartment of Medicine/Hematology and Oncology, University Hospital Heidelberg, Heidelberg cInstitute for Transfusion Medicine and Immunohematology, Goethe University, Frankfurt, Germany dDepartment of Medicine, Division of Hematology, University of Washington, Seattle, WA, USA.
authors.forename: Miriam
authors.initials: M
authors.lastname: Schulz
authors.forename: Halvard
authors.initials: H
authors.lastname: Bonig
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology / Q000627:therapeutic use*; D000068456:Clinical Studies as Topic; D003362:Cost-Benefit Analysis; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008004:Licensure; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D016179:Granulocyte Colony-Stimulating Factor