LAKE FOREST, Ill. — Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.
The company said the phase-3 trial of biosimilar EPO (erythropoietin) would compare its product with Amgen's Epogen in patients with kidney dysfunction who have anemia. The trial, which will enroll about 1,000 patients who already have taken Epogen, follows a phase-1 trial that ended last year, and results of the late-stage trial are expected next year.
"Patient enrollment in our phase-3 EPO program is another important step as Hospira prepares to introduce safe, effective and affordable biosimilars in the United States," Hospira chief science officer and SVP research and development and medical and regulatory affairs Sumant Ramachandra said. "We look forward to offering U.S. patients access to these important medications."
Along with Teva Pharmaceutical Industries and Sandoz, Hospira sells biosimilars in Europe, where they already have been legal for a few years. There, it markets a version of EPO called Retacrit, which it launched in 2008, and in 2010, it launched Nivestim (filgrastim), a biosimilar version of Amgen's Neupogen, used to treat neutropenia, a condition often caused by cancer drugs that causes the body to make too few white blood cells. It also launched Nivestim in Australia last year.