{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T20:01:03Z","timestamp":1776456063947,"version":"3.51.2"},"reference-count":47,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2016,9,16]],"date-time":"2016-09-16T00:00:00Z","timestamp":1473984000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014756","name":"Hexal AG","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014756","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Biosimilar granulocyte\u2010colony\u2010stimulating factors (G\u2010CSFs) 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\u2010CSFs have been largely embraced by the medical community, except for some reservations about healthy\u2010donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>In a two\u2010center safety surveillance study (National Clinical Trial NCT01766934), 245 healthy volunteer stem cell donors were enrolled. Of 244 donors who began mobilization with twice\u2010daily Sandoz biosimilar filgrastim, 242 received a full (n\u2009=\u2009241) or partial (n\u2009=\u20091) course of G\u2010CSF and underwent apheresis. Efficacy and safety were assessed and are reported here.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Biosimilar filgrastim was accompanied by the typical G\u2010CSF class\u2010related adverse effects of expected frequency and severity. Median mobilization for CD34\u2010positive stem cells was 97\/\u00b5L (range, 20\u2010347\/\u00b5L); after one apheresis (91%) or two aphereses (9%) from all but three donors (1.2%), cell doses in excess of the typical 4 \u00d7 10<jats:sup>6<\/jats:sup> CD34\u2010positive cells\/kg of the recipient had been collected (range, 3\u201052 \u00d7 10<jats:sup>6<\/jats:sup>\/kg). Biochemical and hematologic alterations were consistent with previous reports; all had normalized by the first follow\u2010up 1 month after mobilization. Stem cell products engrafted with typical probability and kinetics for G\u2010CSF\u2010mobilized stem cell products.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>These data support the use of biosimilar filgrastim for healthy\u2010donor stem cell mobilization as safe and effective.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.13853","type":"journal-article","created":{"date-parts":[[2016,9,16]],"date-time":"2016-09-16T06:19:51Z","timestamp":1474006791000},"page":"3055-3064","source":"Crossref","is-referenced-by-count":28,"title":["Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte\u2010colony\u2010stimulating factor: safety, efficacy, and graft performance"],"prefix":"10.1111","volume":"56","author":[{"given":"Petra","family":"Becker","sequence":"first","affiliation":[{"name":"Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Donor Service Frankfurt am Main 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