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Published on 29 May 2009

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Quality and purity of biosimilar epoetin zeta (Retacrit®) readily demonstrated in drug product analysis

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Hospira presented two posters at the World Congress of Nephrology (WCN: Milan, Italy, 22–26 May) reporting new data and analysis on epoetin zeta (Retacrit®), its biosimilar epoetin.

Direct analysis of epoetin zeta and epoetin alfa drug product formulations was undertaken in order to provide further assessment of product quality. A study was performed to assess these different product formulations by using and comparing an array of analytical techniques for product characterisation, including reversed-phase high-performance liquid chromatography (RP-HPLC). The RP-HPLC analysis demonstrated that the presence of polysorbate 80 in the formulation of epoetin alfa caused considerable peak interference, with chromatograms of epoetin alfa samples showing greater fragmentation of the main epoetin peak compared with epoetin zeta. The epoetin zeta formulation offers some advantages over epoetin alfa in terms of the drug product analysis performed according to the methods used in this study.

In a post-hoc analysis of an open-label, 56-week follow-up safety trial of 745 patients, epoetin zeta was shown to maintain haemoglobin (Hb) levels in patients with chronic kidney disease (CKD) over the age of 65, with similar safety and tolerability to patients aged 65 and under.

Erythropoeisis-stimulating agents (ESAs) play a significant role in the treatment of patients with anaemia associated with CKD. Biosimilar epoetins are important treatment choices for nephrologists and their patients as they offer high-quality, cost-effective alternatives to existing therapies. As clinical knowledge and experience with epoetin zeta increases, and additional data confirming the quality of the drug product is published, physicians such as Professor Gerhard Lonnemann (professor of medicine, Medizinische Hochschule, Hannover, Germany) are prepared to switch away from established ESAs.

“Biosimilar ESAs have provided both clinicians and patients with a significant alternative treatment option,” commented Professor Lonnemann. “My personal experience is that switching from established ESAs to epoetin zeta in endstage renal disease [ESRD] patients on haemodialysis is easy to handle and effective at maintaining stability in both the total weekly dose and frequency of application. It is also a welcome opportunity to reduce the treatment costs of renal anaemia.”

Accordingly, Hospira sponsored a symposium at WCN entitled “Does biosimilar epoetin meet the needs of the nephrologist?”, chaired by leading nephrologist Professor Andrzej Wiecek, professor of internal medicine and nephrology, and head of the Department of Nephrology, Endocrinology and Metabolic Diseases, at the Medical University of Silesia, Katowice, Poland. Subjects covered included:

  • Evaluating the role of biosimilar erythropoietins and the rationale for adopting them into European clinical practice.
  • Identifying how product quality has been built into the epoetin zeta production and quality assurance process.
  • Presentation of clinical data supporting the efficacy and safety of a biosimilar epoetin (epoetin zeta) in the treatment of anaemia associated with CKD.
  • A nephrologist’s experience in successfully incorporating epoetin zeta into clinical practice.

“With CKD predicted to rise across Europe due to an ageing population and the increased prevalence of obesity and diabetes, data such as that presented at WCN supporting the safety, efficacy and quality of Retacrit [epoetin zeta] will help to build physicians confidence in this innovative treatment option,” said Paul Greenland, biosimilars marketing director, EMEA at Hospira.

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