Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: Results from a randomized, phase i trial

Annals of Hematology

Volumn 89, Issue 9, 2010, Pages 927-933

  Waller, Cornelius F ^a   Bronchud, Miguel ^b   Mair, Stuart ^c   Challand, Rodeina ^d  

^a UNIVERSITY OF FREIBURG   (Germany)

^b HOSPITAL GENERAL DE CATALUNYA   (Spain)

^c CHARLES RIVER LABORATORIES   (United Kingdom)

^d Hospira Ltd   (United Kingdom)

Author keywords

Biosimilar; Filgrastim; G CSF; Neutropenia

Indexed keywords

NIVESTIM; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ADULT; AGITATION; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BIOEQUIVALENCE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; HUMAN EXPERIMENT; INJECTION SITE REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; MEDIASTINUM DISEASE; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; NORMAL HUMAN; ORAL DYSESTHESIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SINGLE DRUG DOSE; THORAX DISEASE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADOLESCENT; ADULT; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; FEMALE; FILGRASTIM; HUMANS; MALE; MIDDLE AGED; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 77955660522     PISSN: 09395555     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00277-010-0961-x     Document Type: Article

References (25)

1. RC Gomez MA Pinto BM Gonzalez 2006 Colony-stimulating factors: clinical evidence for treatment and prophylaxis of chemotherapy-induced febrile neutropenia Clin Transl Oncol 8 729 734 10.1007/s12094-006-0119-4
2. MH Bronchud JH Scarffe N Thatcher D Crowther LM Souza NK Alton NG Testa TM Dexter 1987 Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer Br J Cancer 56 809 813 1:STN:280:DyaL1c7jsVOqsg%3D%3D 2829955
3. MH Bronchud MR Potter G Morgenstern MJ Blasco JH Scarffe N Thatcher D Crowther LM Souza NK Alton NG Testa 1988 In vitro and in vivo analysis of the effects of recombinant human granulocyte colony-stimulating factor in patients Br J Cancer 58 64 69 1:STN:280:DyaL1M%2FgtVClug%3D%3D 2458748
4. AW Roberts 2005 G-CSF: a key regulator of neutrophil production, but that's not all! Growth Factors 23 33 41 10.1080/08977190500055836 1:CAS:528:DC%2BD2MXksVaqtbs%3D 16019425 (Pubitemid 41656869)
5. MS Aapro DA Cameron R Pettengell J Bohlius J Crawford M Ellis N Kearney GH Lyman VC Tjan-Heijnen J Walewski DC Weber C Zielinski 2006 EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours Eur J Cancer 42 2433 2453 10.1016/j.ejca.2006.05.002 1:CAS:528:DC%2BD28XhtVagtrbL 16750358 (Pubitemid 44442936)
6. DC Dale 2002 Colony-stimulating factors for the management of neutropenia in cancer patients Drugs 62 Suppl 1 1 15 10.2165/00003495-200262001-00001 1:CAS:528:DC%2BD38Xot1Wrs7o%3D 12479591
7. K Welte J Gabrilove MH Bronchud E Platzer G Morstyn 1996 Filgrastim (r-metHuG-CSF): the first 10 years Blood 88 1907 1929 1:CAS:528: DyaK28Xlsleku7w%3D 8822908
8. Neupogen 30MU and 48MU solution for injection. Summary of product characteristics. Available at http://emc.medicines.org.uk/document.aspx- documentId=7907 Accessed 2 November 2009
9. Bohlius J, Herbst C, Reiser M, Schwarzer G, Engert A (2008) Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. Cochrane Database Syst Rev CD003189
10. OA Clark GH Lyman AA Castro LG Clark B Djulbegovic 2005 Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomized controlled trials J Clin Oncol 23 4198 4214 10.1200/JCO.2005.05.645 1:CAS:528:DC%2BD2MXmt1els7k%3D 15961767 (Pubitemid 46211326)
11. R Garcia-Carbonero JI Mayordomo MV Tornamira M Lopez-Brea A Rueda V Guillem A Arcediano A Yubero F Ribera C Gomez A Tres JL Perez-Gracia C Lumbreras J Hornedo H Cortes-Funes L Paz-Ares 2001 Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: a multicenter randomized trial J Natl Cancer Inst 93 31 38 10.1093/jnci/93.1.31 1:CAS:528: DC%2BD3MXot1Kitw%3D%3D 11136839
12. NM Kuderer DC Dale J Crawford GH Lyman 2007 Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review J Clin Oncol 25 3158 3167 10.1200/JCO.2006.08.8823 1:CAS:528:DC%2BD2sXptlGrtL4%3D 17634496 (Pubitemid 47218066)
13. GH Lyman NM Kuderer B Djulbegovic 2002 Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis Am J Med 112 406 411 10.1016/S0002-9343(02)01036-7 1:CAS:528:DC%2BD38XitFWmurs%3D 11904116 (Pubitemid 34246271)
14. L Sung PC Nathan SM Alibhai GA Tomlinson J Beyene 2007 Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection Ann Intern Med 147 400 411 17876022
15. Committee for Medicinal Products for Human Use (CHMP). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor. Available at www.emea.europa.eu/pdfs/human/biosimilar/3132905en-pdf. Accessed 28 January 2009
16. Skrlin A, Radic I, Vuletic M, Schwinke D, Runac D (2009) The physicochemical properties of a biosimilar filgrastim are comparable to those of Neupogen®. Poster presentation at the 14th Congress of the European Hematology Association, Berlin, Germany;Abstract 0568
17. U Duhrsen JL Villeval J Boyd G Kannourakis G Morstyn D Metcalf 1988 Effects of recombinant human granulocyte colony-stimulating factor on hematopoietic progenitor cells in cancer patients Blood 72 2074 2081 1:STN:280:DyaL1M%2Fmt1Omtg%3D%3D 3264199
18. C Martinez A Urbano-Ispizua P Marin A Merino M Rovira E Carreras E Montserrat 1999 Efficacy and toxicity of a high-dose G-CSF schedule for peripheral blood progenitor cell mobilization in healthy donors Bone Marrow Transplant 24 1273 1278 10.1038/sj.bmt.1702073 1:STN:280: DC%2BD3c%2FpsVOitA%3D%3D 10627634
19. LM Souza TC Boone J Gabrilove PH Lai KM Zsebo DC Murdock VR Chazin J Bruszewski H Lu KK Chen 1986 Recombinant human granulocyte colony-stimulating factor: effects on normal and leukemic myeloid cells Science 232 61 65 10.1126/science.2420009 1:CAS:528:DyaL28XhvVSksrY%3D 2420009
20. DF Stroncek ME Clay ML Petzoldt J Smith W Jaszcz FB Oldham J McCullough 1996 Treatment of normal individuals with granulocyte-colony-stimulating factor: donor experiences and the effects on peripheral blood CD34+ cell counts and on the collection of peripheral blood stem cells Transfusion 36 601 610 10.1046/j.1537-2995.1996.36796323059.x 1:CAS:528:DyaK28XlsVSgurs%3D 8701455
21. K Welte MA Bonilla AP Gillio TC Boone GK Potter J Gabrilove MAS Moore J O'Reilly LM Souza 1987 Recombinant human granulocyte colony-stimulating factor J Exp Med 165 941 948 10.1084/jem.165.4.941 1:CAS:528:DyaL2sXktVWmsLo%3D 3494094 (Pubitemid 17064496)
22. M Sugiura K Yamamoto Y Sawada T Iga 1997 Pharmacokinetic/pharmacodynamic analysis of neutrophil proliferation induced by recombinant granulocyte colony-stimulating factor (rhG-CSF): comparison between intravenous and subcutaneous administration Biol Pharm Bull 20 684 689 1:CAS:528: DyaK2sXkt1Ohu7w%3D 9212991
23. P Anderlini 2009 Effects and safety of granulocyte colony-stimulating factor in healthy volunteers Curr Opin Hematol 16 35 40 10.1097/MOH. 0b013e328319913c 1:CAS:528:DC%2BD1cXhsVKnu7%2FL 19057203
24. H Lubenau P Bias AK Maly KE Siegler K Mehltretter 2009 Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen®: single-blind, randomized, crossover trial BioDrugs 23 43 51 10.2165/00063030-200923010-00005 1:CAS:528: DC%2BD1MXls1Churw%3D 19344191
25. Waller CF, Semiglazov VF, Chan S, Challand R (2009) Biosimilar filgrastim is an effective primary prophylactic therapy for neutropenia in patients (pts) receiving doxorubicin and docetaxel (AT) for breast cancer (BC). Poster presentation at the joint ECCO 15 and 34th ESMO Multidisciplinary Congress; Abstract E15-1238