Hospira, Inc., announced positive results from a Phase I U.S. clinical trial of its biosimilar erythropoietin (EPO) in patients with renal dysfunction who have anemia. Hospira’s trial met its key endpoint, showing equal pharmacokinetics, or blood level and distribution in the body, for Hospira’s EPO and the reference product, Amgen’s Epogen.
The controlled, randomized trial of 100 patients on hemodialysis who had already been treated with Epogen took place at 20 different hemodialysis centers across the United States. Patients in the trial were treated with both Epogen and Hospira’s EPO, with each patient receiving one drug first and then being switched to the second drug, spending one week on each. Besides showing equivalent pharmacokinetics, the trial showed no difference in patient safety between the two drugs, a secondary endpoint. The positive Phase I results pave the way for Hospira’s planned Phase III U.S. program comparing safety and efficacy of the two products.
“The successful completion of our Phase I EPO trial is an important step for Hospira’s U.S. biosimilars program,” said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira.
The first Phase III U.S. trial, scheduled to begin this year, will be a larger study also involving renal patients. Hospira is consulting with the FDA to plan the trial, which will take place at U.S. hemodialysis centers.
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. In addition, Hospira launched Nivestim, a biosimilar version of filgrastim, in Europe in 2010 and in Australia earlier this year.