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news.Hospira has enrolled the first patient in a Phase III US clinical program for its biosimilar erythropoietin (EPO).
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The study will compare safety and efficacy of Hospira’s EPO and the reference product, Amgen’s Epogen in patients with renal (kidney) dysfunction who have anemia.
Erythropoietin is a treatment for anemia associated with chronic renal failure.
The program will enroll approximately 1,000 patients on hemodialysis who have already been treated with Epogen.
The study is expected to take place at more than 200 different hemodialysis centers across the US. Results are expected in 2013.
The Phase III program is being conducted with the participation of DaVita and Fresenius Medical Care, as well as many dialysis clinics and hospitals across the US.
Hospira R&D and medical & regulatory affairs senior vice president and chief scientific officer Sumant Ramachandra said the company prepares to introduce safe, effective and affordable biosimilars in the US.