The company’s abstract (9564) presented results showing that this European prospective, observational study met the primary endpoint, as defined by haemoglobin treatment response, in the management of chemotherapy-induced anaemia in adult patients with solid tumours, lymphomas and myelomas, regardless of chemotherapy cycle.

The study, called ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) included 2,310 patients with chemotherapy-induced anaemia (Hb < 110 g/L) aged > 18 years with solid tumours, lymphomas or myelomas. The majority of patients (> 80%) achieved an increase in Hb levels to 100 g/L or at least 10 g/L at plus three months. Retacrit was also well tolerated by patients in the study with an overall rate of thrombotic events at 3.5% and no epoetin alpha biosimilar-related deaths being reported.

US-based Hospira gained EMA approval for Retacrit back in December 2007 [1] and has been marketing the product in Europe since early 2008.

Related article

Phase I trial of a biosimilar erythropoietin

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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