LAKE FOREST, Ill.—Hospira said Jan. 10 that it has started enrollment of the first patient in a Phase 3 U.S. clinical program for its biosimilar erythropoietin (EPO).
Hospira's Phase 3 program, which follows a Phase I trial that concluded last year, 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, and will take place at more than 200 different hemodialysis centers across the United States. Results are expected in 2013.
Hospira's Phase 3 program is being conducted with DaVita Inc. and Fresenius Medical Care (NYSE: FMS), as well as many dialysis clinics and hospitals across the United States.
"Patient enrollment in our Phase III EPO program is another important step as Hospira prepares to introduce safe, effective and affordable biosimilars in the United States," said Sumant Ramachandra, MD, PhD, senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "We look forward to offering U.S. patients access to these important medications."
