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Biosimilars Volume 3, 2013 - Issue
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Review

Clinical efficacy and safety of XM01, a biosimilar recombinant human erythropoietin, in the management of anemia

Abdulaziz Mohammed1 Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA;2 College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia
,
Alaa Bagalagel1 Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA;2 College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia
,
Karen MacDonald3 Matrix 45, Tucson, AZ, USA
&
Ivo Abraham1 Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA;3 Matrix 45, Tucson, AZ, USA;4 Department of Pharmacy Practice and Science, College of Pharmacy;5 Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USACorrespondence[email protected]
Pages 45-53 | Published online: 27 Aug 2013

References

  • Abraham I, MacDonald K. Clinical efficacy and safety of HX575, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars. 2012;2:13–25.
  • Bagalagel A, Mohammed A, MacDonald K, Abraham I. Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars. 2013;3:35–43.
  • Barosi G, Bosi A, Abbracchio MP, et al. Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica. 2011;96:937–942.
  • Lonneman G, Macdougall IC. Biosimilar epoetins in renal anemia. Current status and insights from European practice. Eur Nephrol. 2011;5:101–107.
  • European Medicines Agency. Eporatio – summary of the European public assessment report. Available from: http://www.ema.europa. eu/ema/index.jsp?curl=pages/medicines/human/medicines/001033/ human_med_001204.jsp&mid=WC0b01ac058001d124. Updated October 18, 2011. Accessed October 9, 2012.
  • Gertz B, Kohler E, Kes P, et al. Epoetin theta: efficacy and safety of IV administration in anaemic haemodialysis patients in the maintenance phase in comparison to epoetin beta. Curr Med Res Opin. 2010;26:2393–2402.
  • Gertz B, Kes P, Essaian A, et al. Epoetin theta: efficacy and safety of subcutaneous administration in anemic pre-dialysis patients in the maintenance phase in comparison to epoetin beta. Curr Med Res Opin. 2012;28:1101–1110.
  • Tjulandin S, Bias P, Elsässer R, et al. Epoetin theta in anaemic cancer patients receiving platinum-based chemotherapy: a randomised controlled trial. Arch Drug Info. 2010;3:45–53.
  • Tjulandin S, Bias P, Elsässer R, et al. Epoetin theta with a new dosing schedule in anaemic cancer patients receiving nonplatinum- based chemotherapy: a randomised controlled trial. Arch Drug Info. 2011;4:33–41.
  • Abraham I, MacDonald K. Clinical safety of biosimilar recombinant human erythropoietins. Expert Opin Drug Saf. 2012:11:819–840.

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