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State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists

  • Nephrology - Original Paper
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Abstract

The European Medicines Agency (EMA), under a strictly regulated pathway, has approved several biosimilar products since 2005, including biosimilar versions of the erythropoiesis-stimulating agent (ESA) epoetin alfa since 2007. Subsequent to these approvals, the use of biosimilar epoetin alfa in the management of renal anemia has grown steadily throughout Europe. With the enactment of the US Biologics Price Competition and Innovation Act of 2009, a US Food and Drug Administration regulatory approval process for biosimilars was legalized. Thus, biosimilar erythropoietin products are expected to be available for prescription in the USA by mid-decade, presumably at a price that is competitive with the originator brand-name reference products. In this paper, we describe the status of originator and biosimilar ESAs, review the clinical development and regulatory approval of biosimilar erythropoietins in Europe, and summarize relevant efficacy and safety information of biosimilar erythropoietins in relation to their reference products to provide a background for US nephrologists as they appraise biosimilar erythropoietins as treatment options for renal anemia. Key lessons learned from Europe are that (a) EMA-approved biosimilar erythropoietins have comparable efficacy and safety profiles to their reference product erythropoietin; (b) pharmacovigilance preapproval and postapproval are critical, especially with regard to immunogenicity and vascular thromboembolic events; (c) strict preapproval and postapproval requirements must guide the regulatory pathway for biosimilars; and (d) high-quality manufacturing and production processes must be established to ensure quality biosimilar products. The availability of biosimilar erythropoietins in the USA will provide nephrologists with alternative effective, and potentially more affordable, treatment options for patients with renal anemia.

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Acknowledgments

Donna E. Jensen, Ph.D., and Jennifer Stanley, Ph.D., provided medical writing assistance for this publication.

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Authors and Affiliations

  1. Nephrology Department, University of Medicine and Pharmacy “Gr.T.Popa”, Iasi, Romania

    Adrian Covic

  2. Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, 1295 N Martin, Tucson, AZ, 85721, USA

    Ivo Abraham

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Correspondence to Adrian Covic.

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Authors please update and confirm disclosures and update accordingly for gifts of material, grants, and sources of support, and any other potential conflicts of interest received during the past 12 months. A.C. has served as a consultant on biosimilars and/or erythropoiesis-stimulating agents for Amgen, Roche, and Sandoz. I.A. has served as a consultant on biosimilars and/or erythropoiesis-stimulating agents for Amgen, Hospira, Johnson & Johnson, Roche, Sandoz, and Teva through Matrix45. In accordance with Matrix45 company policy, employees are prohibited from owning equity in or contracting independently with client organizations.

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The development of this publication was supported by Hospira, Inc. Editorial comments were provided by Hospira for author consideration, but all content decisions were made by the authors.

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Covic, A., Abraham, I. State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. Int Urol Nephrol 47, 1529–1539 (2015). https://doi.org/10.1007/s11255-015-1042-9

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