Biosimilar Retacrit effective in chemotherapy-induced anemia

Hospira has announced that the results from the ORHEO study (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HaEmatology and Oncology) have been published in BMC Cancer, and show that the company's European biosimilar epoetin, Retacrit (epoetin zeta) was effective and well tolerated in the management of chemotherapy-induced anemia in patients with solid tumours, lymphoma and myeloma.

The ORHEO study, conducted in France to treat oncology patients suffering from chemotherapy-induced anemia due to malignancy, was a prospective, observational study in which 2310 adult patients (99.9% receiving epoetin zeta) were evaluated with chemotherapy-induced anemia and solid tumors, lymphomas or myelomas.

The primary endpoint was the rate of response (defined as an increase in haemoglobin (Hb) levels to at least 10 g/dL since inclusion visit; if there had been an increase in Hb levels of at least 1 g/dL since the inclusion visit; reaching target Hb levels set at start of study, without any blood transfusions in the three weeks prior to measurement) at plus 3 months. The ORHEO study demonstrated that more than 80% of patients receiving Retacrit achieved a pre-defined Hb response in a real-world clinical setting, and that this was maintained at month six. Of the patients in the study, 17.1% experienced an adverse event (AE), in line with rates typically seen for the reference product. Retacrit was well tolerated in this study, with an overall rate of thrombotic events at 3.5%. In this observational study, no epoetin zeta-related deaths were reported.

"Biosimilars have an important role to play in the future of medicine, and because they are more cost effective than their reference products, it is estimated they will save European healthcare systems between €11.8 billion and €33.4 billion between 2007 and 2020," said Stan Bukofzer, corporate vice president and chief medical officer, Hospira. "The ORHEO study provides important information on how Retacrit is benefiting patients in the clinic, and helps to demonstrate the potential of biosimilar epoetins to benefit patients while reducing healthcare costs."