The Quality and Purity of Biosimilar Epoetin Zeta (Retacrit) is Demonstrated Through Comparative Analysis with Epoetin Alfa - Presented at WCN 2009
- Retacrit also shown to maintain haemoglobin (Hb) levels in patients aged 18-75 with Chronic Kidney Disease (CKD) irrespective of age -
MILAN, Italy, May 25, 2009 – Hospira Inc. (NYSE: HSP) today presented two posters at the World Congress of Nephrology 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 quality1. A study was performed to assess these different product formulations by using and comparing an array of analytical techniques for product characterization 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 analysis2 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 Lonnemann are prepared to switch away from established ESAs.
“Biosimilar ESAs have provided both clinicians and patients with a significant alternative treatment option", commented Professor Gerhard Lonnemann, Professor of Medicine at the Medizinische Hochschule, Hannover, Germany. "My personal experience is that switching from established ESAs to epoetin zeta in end stage 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.” says Paul Greenland, Biosimilars Marketing Director, EMEA at Hospira.
About Hospira Hospira is a global speciality pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As a world expert in speciality generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States and has more than 14,000 employees. The head office for Hospira in Europe, Middle East and Africa is in Royal Leamington Spa, UK. Learn more about Hospira at www.hospira.com.
### Notes to editors: Professor Andrzej Wiecek, MD, PhD, FRCP (Edin.) is 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, where he also received his medical training. The author or co-author of more than 530 original papers, reviews and book chapters, his main research interests include clinical aspects of anaemia management in patients with chronic kidney disease, the pathogenesis and clinical aspects of primary and secondary forms of arterial hypertension, hormonal abnormalities in uraemia, kidney transplant and hypertensive patients, and the endocrine function of the kidney and adipose tissue. Professor Wiecek is President of the Polish Society of Nephrology, as well as a member of the European Renal Best Practice and of the European Best Practice Guidelines Working Groups in Anaemia Management and Haemodialysis. He is a council member of the ERA–EDTA (European Renal Association–European Dialysis and Transplantation Association), a Fellow of the Royal College of Physicians of Edinburgh, and sits on the editorial boards of Nephrology, Dialysis and Transplantation (Subject Editor) and Clinical Nephrology.
Professor Gerhard Lonnemann, MD, PhD, FRCP (Edin.), a former scholar at Tufts University School of Medicine, Boston, Massachusetts, USA, is Professor of Medicine at the Medizinische Hochschule Hannover, Germany, where he also received his medical training. In addition, he is an Internist and Specialist in Nephrology for the Gemeinschaftspraxis Nephrologie/Dialyse, a nephrology and dialysis clinic in Langenhagen. Professor Lonnemann has authored or co-authored 80 publications in peer-reviewed journals. His main scientific interests include mechanisms of cytokine induction in haemodialysis, the role of inflammation in chronic kidney disease, sepsis, the treatment of acute renal failure, uraemia and cellular immunity, and the influence of dialysis treatment. In addition, Professor Lonnemann has participated in a number of multi-centre clinical trials, including NESP, SHARP, OPTIMA and STRATE.
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1 Schwinke D et al. Formulation Interference: A Comparative Analysis of Epoetin Zeta (Retacrit) and Epoetin Alfa (Eprex/Erypo). Abstract no: 951246, presented at the World Congress of Nephrology, 22-25 May, Milan. 2 Wiecek A et al. Long-term Follow-up Safety Study of Epoetin Zeta: Post Hoc Sub Analysis by Age of Patients with Chronic Kidney Disease. Abstract no: 952477, presented at the World Congress of Nephrology, 22-25 May, Milan.
Posted: May 2009