Clinical efficacy and safety of Tevagrastim ® (XM02), a biosimilar recombinant human granulocyte colony-stimulating factor

Giovanna Andreola, Aleksandra Babic, Cristina Rabascio, Mara Negri, Giovanni Martinelli, Daniele Laszlo, 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. ,vol. 88, pp. 154- 158 ,(2012) , 10.1111/J.1600-0609.2011.01719.X

A del Giglio, A Eniu, D Ganea-Motan, E Topuzov, H Lubenau, XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy BMC Cancer. ,vol. 8, pp. 332- 332 ,(2008) , 10.1186/1471-2407-8-332

A. Engert, L. Griskevicius, Y. Zyuzgin, H. Lubenau, A. del Giglio, 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. Leukemia & Lymphoma. ,vol. 50, pp. 374- 379 ,(2009) , 10.1080/10428190902756081

Ulrich Gatzemeier, Tudor Ciuleanu, Mircea Dediu, Elena Ganea-Motan, Heinz Lubenau, Auro Del Giglio, XM02, the First Biosimilar G-CSF, is Safe and Effective in Reducing the Duration of Severe Neutropenia and Incidence of Febrile Neutropenia in Patients with Small Cell or Non-small Cell Lung Cancer Receiving Platinum-Based Chemotherapy Journal of Thoracic Oncology. ,vol. 4, pp. 736- 740 ,(2009) , 10.1097/JTO.0B013E3181A52964

D Metcalf, The granulocyte—Macrophage colony stimulating factors Cell. ,vol. 43, pp. 5- 6 ,(1985) , 10.1016/0092-8674(85)90004-2

Ivo Abraham, Soba Tharmarajah, Karen MacDonald, Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors. Expert Opinion on Drug Safety. ,vol. 12, pp. 235- 246 ,(2013) , 10.1517/14740338.2013.770472

Yoshito Kaziro, Tatsumi Yamazaki, Osami Yamamoto, Yuichi Hirata, Naoki Kubota, Masayoshi Oheda, Hitoshi Nomura, Masayoshi Ono, Shigekazu Nagata, Masayuki Tsuchiya, Shigetaka Asano, Molecular cloning and expression of cDNA for human granulocyte colony-stimulating factor. Nature. ,vol. 319, pp. 415- 418 ,(1986) , 10.1038/319415A0

V. Trillet-Lenoir, J. Green, C. Manegold, J. Von Pawel, U. Gatzemeier, B. Lebeau, A. Depierre, P. Johnson, G. Decoster, D. Tomita, C. Ewen, Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy European Journal of Cancer. ,vol. 29, pp. 319- 324 ,(1993) , 10.1016/0959-8049(93)90376-Q

Ivo Abraham, Mohammed, Bagalagel, Karen MacDonald, Clinical efficacy and safety of XM01, a biosimilar recombinant human erythropoietin, in the management of anemia Biosimilars. ,vol. 3, pp. 45- 53 ,(2013) , 10.2147/BS.S28709

Lawrence M Souza, Thomas C Boone, Janice Gabrilove, Por H Lai, Krisztina M Zsebo, Douglas C Murdock, Vicki R Chazin, Joan Bruszewski, Hsieng Lu, Kenneth K Chen, Jean Barendt, Erich Platzer, Malcolm AS Moore, Roland Mertelsmann, Karl Welte, Recombinant human granulocyte colony-stimulating factor: effects on normal and leukemic myeloid cells Science. ,vol. 232, pp. 61- 65 ,(1986) , 10.1126/SCIENCE.2420009