Date: 2015-03-27
Type of
information: Presentation of results at a congress
phase: post-marketing
Announcement: presentation of results at the National Kidney Foundation (NKF) spring meeting
Company: Hospira (USA - IL)
Product: Retacrit™, European biosimilar epoetin
Action
mechanism: erythropoiesis-stimulating agent/biosimilar. This biosimilar product is a erythropoiesis-stimulating agent. Retacrit®, a recombinant human erythropoietin, or an"EPO biosimilar," was launched in Europe in early 2008. Retacrit is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma.
Disease: chemotherapy-induced anemia
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On March 27, 2015, Hospira presented two studies that support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the FDA conditionally approved name of Retacrit™, compared to the reference product, Amgen's Epogen™ (epoetin alfa). These study data were presented at the National Kidney Foundation (NKF) spring meeting in abstracts titled "PK/PD Equivalence of Epoetin Hospira and Epogen Following Single Subcutaneous Doses to Healthy Subjects," and "Epoetin Hospira and Epogen PK/PD Equivalence Following Multiple Subcutaneous Doses to Healthy Subjects."Both randomized, open-label, active-controlled studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Epoetin Hospira compared to Amgen's reference product, Epogen (epoetin alfa), administered by subcutaneous injection in healthy volunteers. One study evaluated a single dose of 100 Units/kg, and the other study evaluated multiple doses of 100 Units/kg administered three times per week for a total of four weeks. The studies included measuring the effect of well-established PD clinical markers of reticulocyte count and hemoglobin, which were equivalent between Epoetin Hospira and Epogen in both studies. These markers were selected because they are directly reflective of the mechanism of action of epoetin alfa and, based on literature, are known to directly correlate with clinical effects.
- • On June 3, 2013, Hospira has announced results from a post-marketing study of the company\'s European biosimilar epoetin, Retacrit™. This prospective, observational study met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit® was well tolerated by patients in the study. (Abstract 9564 - Epoetin biosimilars in the management of anemia secondary to chemotherapy in patients with solid tumors, lymphomas, and myelomas: The ORHEO study.). This European prospective, observational study included 2,310 patients with solid tumors, lymphomas or myelomas. The majority of patients (>80 percent) enrolled in this study achieved a pre-defined hemoglobin (Hb) response with Retacrit in a real-world clinical setting. Retacrit was well tolerated in this study with an overall rate of thrombotic events at 3.5 percent. In this observational study, no epoetin alfa biosimilar-related deaths were reported. This study is the first post-marketing observation study conducted in France for a biosimilar.
Is
general: Yes
