Hospira, Inc., announced enrollment of the first patient in a Phase III U.S. clinical program for its biosimilar erythropoietin (EPO).
Hospira’s Phase III program, which follows a successful 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 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.
“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, M.D., Ph.D., 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.”
Hospira already sells a biosimilar EPO in Europe, Retacrit and is the first and only North American-headquartered company with biosimilars on the European market and in Australia. Retacrit was introduced in early 2008, and Hospira launched Nivestim, a biosimilar version of filgrastim, in Europe in 2010 and in Australia last year.
Hospira’s Phase III program is being conducted with the participation of DaVita Inc. and Fresenius Medical Care, as well as many dialysis clinics and hospitals across the United States.
Source: Hospira Press Release