Biosimilar epoetin shows good safety profile in post-authorization study

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Biosimilar epoetin shows good safety profile in post-authorization study

Biosimilares/Investigación | Posted 16/05/2014 0 Post your comment

US-based generics manufacturer Hospira announced on 28 April 2014 positive results from a post-authorization observational safety study of its biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anaemia [1].

The post-authorization safety cohort observational study (PASCO I) was carried out in four European countries and included 1,634 anaemic patients with chronic kidney disease receiving haemodialysis and who were treated with Retacrit/Silapo administered intravenously for up to one year. The primary objective of PASCO I was to determine the incidence of adverse events of special interest (AESI) and lack of efficacy events in patients being treated with Retacrit/Silapo for renal anaemia.

AESI frequencies were thromboembolic events 6.4% (n = 105), cerebrovascular events 1.8% (n = 30) and clotting of artificial kidney 9.8% (n = 160). There were no reports of pure red cell aplasia, neutralizing antibodies, anaphalactoid reactions or angioedema. Lack of efficacy occurred in 2.4% of subjects (n = 39), although 27 of these cases were attributed to infection or inflammation.

The results of the study, which were conducted as part of the risk management plan (RMP) post-approval commitment to the European Medicines Agency (EMA), were presented at the National Kidney Foundation’s 2014 Spring Clinical Meetings. The data showed that the safety pattern for Retacrit/Silapo was comparable with known data for other existing epoetin products.

Retacrit is marketed in Europe by Hospira and Silapo is marketed in Germany by Cell Pharm, a subsidiary of STADA Arzneimittel. Hospira and STADA Arzneimittel are currently conducting an additional post-authorization safety cohort observational study (PASCO II) intended to further the safety profile of Retacrit/Silapo given subcutaneously over a period of three years in 6,700 European patients being treated for anaemia associated with renal disease. As with PASCO I, this study is also being conducted as part of an RMP commitment to EMA for further pharmacovigilance surveillance.

Conflict of interest
Several of the authors of the research paper [1] reported conflicts of interest, including having received honoraria, consultancy fees or principal investigator fees from pharmaceutical companies or being employees of STADA Arzneimittel or Hospira. For more details see [1].

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Reference
1. Dellanna F, Fluck R, Lonnemann G, Wild CA, Iwanowitsch A, Meissner R, et al. Results from a safety study of patients with renal anemia receiving the biosimilar Retacrit™ / Silapo™ (epoetin zeta): the PASCO I study. Poster 64. National Kidney Foundation 2014 Spring Clinical Meetings; 22-26 April 2014; Las Vegas, USA.

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Source: Hospira