Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte‐colony‐stimulating factor: safety, efficacy, and graft performance

• DOI: 10.1111/trf.13853
• Publication Date: 2016-09-16T06:19:51Z
• Authors: Petra Becker; Arnd Schwebig; Susanne Brauninger; Heike Bialleck; Beate Luxembourg; Miriam Schulz; Chrysanthi Tsamadou; Markus Wiesneth; Peter Reinhardt; Joannis Mytilineos; Christian Seidl; Sreekanth Gattu; Natalia Kaliakina; Pritibha Singh; Hubert Schrezenmeier; Erhard Seifried; Halvard Bonig
• Keywords: Biosimilar; Plerixafor; Mobilization

Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved United States March 2015 for all of reference product's indications except acute radiation syndrome. G-CSFs largely embraced by medical community, some reservations about healthy-donor stem cell mobilization, which use outside clinical studies cautioned against members scientific community.In a two-center safety surveillance study (National Clinical Trial NCT01766934), 245 healthy volunteer donors were enrolled. Of 244 who began mobilization with twice-daily Sandoz filgrastim, 242 received full (n = 241) or partial 1) course G-CSF underwent apheresis. Efficacy assessed are reported here.Biosimilar accompanied typical class-related adverse effects expected frequency severity. Median CD34-positive cells 97/µL (range, 20-347/µL); after one apheresis (91%) two aphereses (9%) from but three (1.2%), doses excess 4 × 106 cells/kg recipient had collected 3-52 /kg). Biochemical hematologic alterations consistent previous reports; normalized first follow-up 1 month mobilization. Stem products engrafted probability kinetics G-CSF-mobilized products.These data support as safe effective.