Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association.

نویسندگان

  • Bronwen E Shaw
  • Dennis L Confer
  • William Y Hwang
  • Derwood H Pamphilon
  • Michael A Pulsipher
چکیده

zeta, administered intravenously, for maintenance treatment of renal anemia. Adv Ther. 2008;25(11):1215-28. 12. Krivoshiev S, Todorov VV, Manitius J, Czekalski S, Scigalla P, Koytchev R. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin. 2008;24(5):1407-15. 13. Wizemann V, Rutkowski B, Baldamus C, Scigalla P, Koytchev R. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008;24(3):625-37. 14. Krivoshiev S, Wizemann V, Czekalski S, Schiller A, Pljesa S, WolfPflugmann M, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther. 2010;27:105-17. 15. http://www.gabionline.net/Biosimilars/News/Safety-study-forsubcutaneous-epoetin-alfa-biosimilar-Binocrit-Epoetin-alfa-HexalAbseamed-suspended 16. Bouchet JL, Brunet P, Canaud B, Chanliau J, Combe C, Deray G, et al. Société de néphrologie, Société francophone de dialyse, Société de néphrologie pédiatrique; Société francophone de dialyse; Société de néphrologie pédiatrique. [Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société Francophone de dialyse, and Société de néphrologie pédiatrique]. Nephrol Ther. 2009;5(1):61-6. 17. Covic A, Cannata-Andia J, Cancarini G, Coppo R, Frazão JM, Goldsmith D, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know—a position paper by the ERA-EDTA Council. Nephrol Dial Transplant. 2008;23(12):3731-7. 18. European Medicines Agency. Assessment Report for epoetin alfa Binocrit. Nonproprietary Name: epoetin alfa. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Scientific_Discussion/human/000725/WC500053615.pdf 19. Weigang-Köhler K, Vetter A, Thyroff-Friesinger U. HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated aymptomatic anaemia in patients with solid tumours. Onkologie. 2009;32(4):168-74. 20. Tzekova V, Mihaylov G, Elezovic I, Koytchev R; Epoetin Zeta Oncology Study Group. Therapeutic effects of epoetin zeta in the treatment of chemotherapy-induced anaemia. Curr Med Res Opin. 2009;25(7):1689-97. 21. del Giglio A, Eniu A, Ganea-Motan D, Topuzov E, Lubenau H. 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. 2008;8:332. 22. Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, Del Giglio A. 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. J Thorac Oncol. 2009;4(6): 736-40. 23. Engert A, Griskevicius L, Zyuzgin Y, Lubenau H, del Giglio A. 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. Leuk Lymphoma. 2009;50(3):374-9. 24. Engert A, del Giglio A, Bias P, Lubenau H, Gatzemeier U, Heigener D. Incidence of Febrile Neutropenia and Myelotoxicity of chemotherapy: A Meta-Analysis of Biosimilar G-CSF Studies in Breast Cancer, Lung Cancer, and Non-Hodgkin’s Lymphoma. Onkologie 2009;32:599-604 10.1159/000232580) 25. European Medicines Agency. Assessment report for biograstim. Available at: http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Summary_for_the_public/human/000826/ WC500053902.pdf. 26. Waller CF, Semiglazov VF, Tjulandin S, Bentsion D, Chan S, Challand R. A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Onkologie. 2010;33(10):504-11. 27. www.gitmo.net/Biosimilars_ in%20mobilization%20of%20unrelated%20and%20related%20donors.pdf. 28. ww.worldmarrow.org/fileadmin/.../CWG/.../CWG_Minutes_032009.pdf 29. Niederwieser-D, Schmitz S. Biosimilar agents in oncology/haematology: from approval to practice. Eur J Haematol. 2011;86(4):277-88. 30. East Midlands guidelines, www.inrcancernetwork.nhs.uk 31. Publicover A, Richardson DS, Hill K, et al. Use of biosimilar granulocyte colony stimulating factor (GCSF) for peripheral blood progenitor cell mobilisation prior to autologous stem cell transplant: a single centre experience. Bone Marrow Transplant 2010;45(suppl 2):S158. 32. Gastl G, Geissler D, Geissler K, Lang A, Ludwig H, et al. ASHO position paper on biosimilars. MEMO 2009;2:232-233. 33. Atkins H. Hematopoietic SCT for the treatment of multiple sclerosis. Bone Marrow Transplant. 2010;45(12):1671-81. 34. Wiȩcek A, Ahmed I, Scigalla P, Koytchev R. Switching epoetin alfa and epoetin zeta in patients with Renal Anemia on Dialysis: Posthoc analysis. Adv Ther. 2010;27(12):941-52. 35. Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology a single-dialysis center experience. Clin Nephrol. 2011;75(1):59-62. 36. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-9. 37. WHO. Guidance on INN. Available from: http://www.who.int/medicines/services/inn/innquidance/en/index.htmlWHO. Editorials and Perspectives

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عنوان ژورنال:
  • Haematologica

دوره 96 7  شماره 

صفحات  -

تاریخ انتشار 2011