Back to Journals » Biosimilars » Volume 3

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

Authors Mohammed A, Bagalagel A, MacDonald K, Abraham I

Received 21 December 2012

Accepted for publication 28 February 2013

Published 27 August 2013 Volume 2013:3 Pages 45—53

DOI https://doi.org/10.2147/BS.S28709

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 5

Abdulaziz Mohammed,1,2 Alaa Bagalagel,1,2 Karen MacDonald,3 Ivo Abraham1,3–5

1Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA; 2College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 3Matrix45, Tucson, AZ, USA; 4Department of Pharmacy Practice and Science, College of Pharmacy, 5Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA

Abstract: In this third paper of a series of three reviews on approved biosimilar erythropoietins, we review the evidence about the clinical efficacy and safety of XM01 (epoetin theta). XM01 was developed as a stand-alone product but is considered clinically as a biosimilar. As in the preceding reviews, clinical efficacy is assessed as a function of therapeutic equivalence of biosimilar versus reference product and, in the cancer setting, also superiority over placebo; while safety is evaluated in terms of immunogenicity, venous thromboembolism and mortality. Four studies on patients with chronic kidney disease and three studies on oncology patients are reviewed. In the renal setting, these include two randomized controlled trials on hemoglobin maintenance in hemodialysis and predialysis patients; as well as two open-label extension studies in these populations that also include Phase II patients. Studies in the cancer setting include three randomized controlled trials; in patients with solid tumors receiving platinum-based chemotherapy, in patients with either solid tumors or hematological malignancies receiving non-platinum based chemotherapy, and in patients with hematological malignancies undergoing antineoplastic therapy. Based on the available data, the clinical and safety outcomes of treatment with XM01 are likely to be similar to those of the comparator product NeoRecormon® and superior over placebo. Both XM01 and NeoRecormon® can be considered interchangeable in the management of anemia in the approved indications. Patients transferred from reference product to biosimilar can be expected to show the same efficacy and safety outcomes. There is no evidence for the interchangeability of XM01 with other biosimilar or originator erythropoietins. In keeping with EMA guidance about traceability, it is recommended that clinicians document the product prescribed by its commercial name, especially when switching patients from originator to biosimilar or vice versa.

Keywords: biosimilars, biosimilar pharmaceuticals, efficacy, safety, erythropoietin, recombinant proteins

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF] 

 

Other articles by this author:

Clinical efficacy and safety of Zarzio® (EP2006), a biosimilar recombinant human granulocyte colony-stimulating factor

Tharmarajah S, Mohammed A, Bagalagel A, MacDonald K, Abraham I

Biosimilars 2014, 4:1-9

Published Date: 12 March 2014

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

Bagalagel A, Mohammed A, MacDonald K, Abraham I

Biosimilars 2013, 3:55-62

Published Date: 27 August 2013

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

Bagalagel A, Mohammed A, MacDonald K, Abraham I

Biosimilars 2013, 3:35-43

Published Date: 21 August 2013

Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program

Abraham I, MacDonald K, Hermans C, Aerts A, Lee C, Brié H, Vancayzeele S

Vascular Health and Risk Management 2011, 7:209-235

Published Date: 31 March 2011

Readers of this article also read:

Emerging and future therapies for hemophilia

Carr ME, Tortella BJ

Journal of Blood Medicine 2015, 6:245-255

Published Date: 3 September 2015

A new recombinant factor VIII: from genetics to clinical use

Santagostino E

Drug Design, Development and Therapy 2014, 8:2507-2515

Published Date: 12 December 2014

Is increasing the dose of Entecavir effective in partial virological responders?

Erturk A, Adnan Akdogan R, Parlak E, Cure E, Cumhur Cure M, Ozturk C

Drug Design, Development and Therapy 2014, 8:621-625

Published Date: 29 May 2014

Green synthesis of water-soluble nontoxic polymeric nanocomposites containing silver nanoparticles

Prozorova GF, Pozdnyakov AS, Kuznetsova NP, Korzhova SA, Emel’yanov AI, Ermakova TG, Fadeeva TV, Sosedova LM

International Journal of Nanomedicine 2014, 9:1883-1889

Published Date: 16 April 2014

A novel preparation method for silicone oil nanoemulsions and its application for coating hair with silicone

Hu Z, Liao M, Chen Y, Cai Y, Meng L, Liu Y, Lv N, Liu Z, Yuan W

International Journal of Nanomedicine 2012, 7:5719-5724

Published Date: 12 November 2012

Cross-linked acrylic hydrogel for the controlled delivery of hydrophobic drugs in cancer therapy

Deepa G, Thulasidasan AK, Anto RJ, Pillai JJ, Kumar GS

International Journal of Nanomedicine 2012, 7:4077-4088

Published Date: 27 July 2012