REVIEW ARTICLE

BIOSIMILAR ESAs: A COMPARATIVE REVIEW Paul Wilson1, Cheryl Wood2 Darent Valley Hospital, Darenth Wood Road, Dartford, Kent, UK 2 King’s College Hospital NHS Foundation Trust, Denmark Hill, London, UK

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Wilson P., Wood C. (2015). Biosimilar ESAs: A comparative review. Journal of Renal Care 41(1), 53–61.

SUMMARY 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.

K E Y W O R D S Anaemia  Biosimilar  Epoetin  Chronic kidney disease

INTRODUCTION Caring for patients with kidney disease is typically a long-term commitment with unique risks and challenges for healthcare

BIODATA Paul Wilson completed his nursing training in New Zealand and now works as the Renal Clinical Nurse Specialist at Darent Valley Hospital, Dartford, Kent, UK. He has previously worked across all areas of nephrology within the NHS and has also worked in the private sector. He currently is a member the executive committee of the Anaemia Nurse Specialist Association (ANSA). CORRESPONDENCE

Paul Wilson, Clinical Nurse Specialist & Service Development Lead, Department of Urology and Renal, Darent Valley Hospital, Darenth Wood Road, Dartford, Kent DA2 8DA, UK Tel.: þ44 13 2242 8100 Email: [email protected]

professionals (HCPs) including actively managing the disease, such as treatment of anaemia with erythropoietin-stimulating agents (ESAs) and intravenous (IV) iron and involving patients and their families in treatment decisions whilst working with multidisciplinary teams effectively (Isles et al. 2011). Nurses have a pivotal role in patient care, not only administering medications but also monitoring response and educating patients about their medication. It is therefore essential that nurses possess appropriate knowledge of the medication that they administer. This article provides an update on the treatment options for anaemia associated with chronic kidney disease (CKD), enabling renal nurses to engage in informed discussions with their patients.

CKD AND RENAL ANAEMIA People with CKD often have a deficiency in erythropoietin production and anaemia is a common comorbidity of CKD (Babitt & Lin 2012). The risk of anaemia increases with the degree of renal impairment; 60–80% of patients with end-stage kidney disease (ESKD) are affected (see Table 1) (Strippoli et al. 2006). Anaemia in CKD is associated with a variety of clinical symptoms ranging from fatigue (Odden et al. 2004) to neurocognitive dysfunction, thus affecting overall quality of life

© 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association

Journal of Renal Care 2015

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Wilson and Wood

Stage of CKD Early Stage 4: GFR 25–34 ml/min/1.73 m2 Late Stage 4/Stage 5: GFR

Biosimilar ESAs: a comparative review.

The management of anaemia in patients with chronic kidney disease has been transformed by development of erythropoiesis-stimulating agents (ESAs). Fol...
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