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Original Articles Clinical

XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy

, MD, , , &
Pages 374-379 | Received 15 Sep 2008, Accepted 16 Jan 2009, Published online: 01 Jul 2009

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Alaa Bagalagel, Abdulaziz Mohammed, Karen MacDonald & Ivo Abraham. (2013) Clinical efficacy and safety of Tevagrastim® (XM02), a biosimilar recombinant human granulocyte colony-stimulating factor. Biosimilars 3, pages 55-62.
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J.J. Vehreschild, A. Böhme, O.A. Cornely, C. Kahl, M. Karthaus, K.-A. Kreuzer, G. Maschmeyer, S. Mousset, V. Ossendorf, O. Penack, M.J.G.T. Vehreschild & J. Bohlius. (2014) Prophylaxis of infectious complications with colony-stimulating factors in adult cancer patients undergoing chemotherapy—evidence-based guidelines from the Infectious Diseases Working Party AGIHO of the German Society for Haematology and Medical Oncology (DGHO). Annals of Oncology 25:9, pages 1709-1718.
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Steven Lucio. (2017) Clinical and Formulary Considerations for Biosimilars. Hospital Pharmacy 49:1_suppl, pages 6-12.
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Pere Gasc?n, Hans Tesch, Karl Verpoort, Maria Sofia Rosati, Nello Salesi, Samir Agrawal, Nils Wilking, Helen Barker, Michael Muenzberg & Matthew Turner. (2013) Clinical experience with Zarzio? in Europe: what have we learned?. Supportive Care in Cancer 21:10, pages 2925-2932.
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M Schmitt, X Xu, I Hilgendorf, C Schneider, K Borchert, D Gläser, M Freund & A Schmitt. (2013) Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors. Bone Marrow Transplantation 48:7, pages 922-925.
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Serdar Sivgin, Esen Karakus, Leylagul Kaynar, Fatih Kurnaz, Cigdem Pala, Muzaffer Keklik, Gokmen Zararsiz, Musa Solmaz, Bulent Eser, Mustafa Cetin & Ali Unal. (2013) The comparison of Filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) as a first line peripheral blood stem cell mobilization strategy in autologous hematopoieitic stem cell transplantation: A single center experience from Turkey. Transfusion and Apheresis Science 48:3, pages 315-320.
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Walter Hinderer. 2012. Pharmaceutical Biotechnology. Pharmaceutical Biotechnology 285 335 .
Patricia Gravel, Aarti Naik & Jean-Yves Le Cotonnec. (2012) Biosimilar rhG-CSFs: how similar are they?. Targeted Oncology 7:S1, pages 3-16.
Crossref
Giovanna Andreola, Aleksandra Babic, Cristina Rabascio, Mara Negri, Giovanni Martinelli & Daniele Laszlo. (2011) Plerixafor and Filgrastim XM02 (Tevagastrim ® ) as a first line peripheral blood stem cell mobilisation strategy in patients with multiple myeloma and lymphoma candidated to autologous bone marrow transplantation . European Journal of Haematology 88:2, pages 154-158.
Crossref
George Morstyn. 2012. Twenty Years of G-CSF. Twenty Years of G-CSF 3 13 .
François Lefrère, Anne-Colette Brignier, Caroline Elie, Jean-Antoine Ribeil, Michael Bernimoulin, Charbel Aoun, Liliane Dal Cortivo, Richard Delarue, Olivier Hermine & Marina Cavazzana-Calvo. (2011) First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony- stimulating factor. Advances in Therapy 28:4, pages 304-310.
Crossref
M.S. Aapro, J. Bohlius, D.A. Cameron, Lissandra Dal Lago, J. Peter Donnelly, N. Kearney, G.H. Lyman, R. Pettengell, V.C. Tjan-Heijnen, J. Walewski, Damien C. Weber & C. Zielinski. (2011) 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. European Journal of Cancer 47:1, pages 8-32.
Crossref
D. Spoerl & Andreas J. Bircher. 2011. A worldwide yearly survey of new data in adverse drug reactions. A worldwide yearly survey of new data in adverse drug reactions 769 814 .
P. García Alfonso. (2010) Filgrastim biosimilar: desde el desarrollo al registro. Farmacia Hospitalaria 34, pages 19-24.
Crossref
. (2009) Current awareness: Pharmacoepidemiology and drug safety. Pharmacoepidemiology and Drug Safety 18:11.
Crossref

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