Hospira's biosimilar Retacrit shows good safety profile in post-authorization study

USA-based Hospira (NYSE: HSP) has announced positive results from a post-authorization observational safety study of biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anemia.

The study's results, presented at the National Kidney Foundation 2014 Spring Clinical Meetings, exhibited a safety pattern for Retacrit/Silapo comparable with known data for other epoetin alfa products. The study, PASCO I (post-authorization safety cohort observational study), included anemic patients with chronic kidney disease receiving hemodialysis and who were treated with Retacrit/Silapo administered intravenously for up to one year. Hospira conducted the study in conjunction with Germany’s STADA Arzneimittel (SAZ: GR) as part of the risk-management plan (RMP) post-approval commitment to the European Medicines Agency (EMA), and included safety data from more than 1,600 patients in four European countries. Around 94% of patients were treated previously with an erythropoiesis stimulating agent (ESA). The primary objective of PASCO I was to determine the incidence of adverse events of special interest (AESI) in patients being treated with Retacrit/Silapo for renal anemia.

In the patients studied, treatment of renal anemia with Retacrit/Silapo was found to have a safety profile consistent with that found in the Retacrit/Silapo registration trials with the same route of administration and in line with other ESAs.