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Biosimilars Volume 3, 2013 - Issue
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Review

Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia

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
,
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
,
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 35-43 | Published online: 21 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.
  • European Medicines Agency. Retacrit – summary of the European public assessment report. Available from: http://www.ema.europa. eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/ human_med_001031.jsp&mid=WC0b01ac058001d124. Updated: October 18, 2011. Accessed October 9, 2012.
  • Abraham I, MacDonald K. Clinical safety of biosimilar recombinant human erythropoietins. Expert Opin Drug Saf. 2012;11(5):819–840.
  • Krivoshiev S, Todorov VV, Manitius J, et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alfa in the correction of renal anaemia. Curr Med Res Opin. 2008;24:1407–1415.
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  • Baldamus C, Krivoshiev S, Wolf-Pflugmann, et al. Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia. Adv Ther 2008;25:1215–1228.
  • Krivoshiev S, Wizemann V, Czekalski S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther. 2010;27:105–117.
  • Wiçcek 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;27:941–952.
  • Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology – a single dialysis center experience. Clin Nephrol. 2011;75:59–62.
  • Tzekova V Mihaylov G, Elezovic I, et al. Therapeutic effects of epoetin zeta in the treatment of chemotherapy-induced anaemia. Curr Med Res Opin. 2009;25:1689–1697.
  • Kumvhev E, Koytchev R, Dimitrakov D, et al. Effect of epoetin zeta for correction of renal anemia in hemodialysis patients with thalassemia minor. Adv Ther. 2008;25:1375–1378.

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