Positive post-marketing data for biosimilar epoetin

Biosimilars/Research | Posted 07/06/2013 post-comment0 Post your comment

Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, USA.

Erythropoietin V13F07

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.

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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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Source: Hospira

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