LAKE FOREST, Ill.—Hospira Inc. said it will start phase 3 trials of its biosimilar erythropoietin (EPO) after receiving positive results from a phase 1 clinical trial in kidney disease patients with anemia.
Hospira said the phase 1 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. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.
The phase I study was conducted with the participation of DaVita Inc. and Fresenius Medical Care AG & Co. KGaA . Although phase 1 trials are most often conducted with healthy volunteers, Hospira received FDA approval to conduct its phase 1 trial with renal patients.
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, according to Hospira.
"The successful completion of our phase 1 EPO trial is an important step for Hospira's U.S. biosimilars program," said Sumant Ramachandra, MD, PhD, senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "We look forward to starting our Phase 3 U.S. program, and are committed to building on our success with biosimilars in Europe and Australia by making affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."
The first phase3 U.S. trial, scheduled to begin this year, will be a larger study also involving renal patients. Hospira is consulting with the U.S. Food and Drug Administration (FDA) to plan the trial, which will take place at U.S. hemodialysis centers.