Biosimilar ESAs: a comparative review

Paul Wilson, Cheryl Wood
Journal of Renal Care 2015, 41 (1): 53-61

BACKGROUND: The management of anaemia in patients with chronic kidney disease has been transformed by development of erythropoiesis-stimulating agents (ESAs). Following expiry of the patent of the originator epoetin alfa in Europe, a number of biosimilar ESAs have been licensed for use in the nephrology setting. Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that they have demonstrated comparable safety, efficacy and quality to their reference product.

OBJECTIVES: As nurses have a pivotal role in patient care, not only administering medications but also educating patients about their treatment options, it is important that nurses understand the differences between biosimilar medicines and their reference products and appreciate the stringent regulatory requirements for approval of biosimilars.

METHODS: In this review, we use epoetin zeta as a case study to highlight practical considerations of using biosimilar ESAs in the management of patients with kidney disease.

RESULTS AND CONCLUSION: Biosimilar products, such as epoetin zeta, may offer a range of features to patients, nurses and physicians, such as greater flexibility over dose and route of administration, in addition to greater access to biological medicines through cost savings.

APPLICATION TO PRACTICE: Renal nurses play a significant role in the management of patients with kidney disease and anaemia, not only having an important role in the delivery of medicine but also in the education of patients. This review discusses some of the practical aspects associated with the use of biosimilar medicines to assist nurses in making informed decisions over their use.

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