LAKE FOREST, Ill.—Hospira Inc. has started the early phases of a clinical trial for its biosimilar erythropoietin (EPO) in patients with renal dysfunction who have anemia, the company said in a July 26 news release.
Hospira, which specializes in generic injectable pharmaceuticals, will perform the Phase I clinical trial at 20 different hemodialysis centers across the United States. DaVita Inc. and Fresenius Medical Care, the two largest U.S. dialysis providers, will be participating in the study with Hospira.
Phase I trials are usually conducted with healthy volunteers, but Hospira said it received U.S. Food and Drug Administration approval to conduct its Phase I trial with patients.
In the trial, patients will be treated with Amgen’s Epogen and Hospira's EPO, with each patient receiving one drug first and then being switched to the second drug. The goal of the Phase I trial is to test safety and pharmacokinetics, or measurements of the drug's blood level and distribution in the body, compared with the reference product, according to Hospira.
Pending successful completion of the Phase I trial, Hospira said it would launch an expanded Phase III trial in 2011, also comparing safety and efficacy of Hospira's EPO with Epogen.
"This trial marks a key milestone for Hospira's biosimilars program," said Sumant Ramachandra, MD, PhD, senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira."Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."
Hospira already sells a biosimilar EPO in Europe called Retacrit, which was introduced in early 2008. According to Hospira, their EPO drug now has a more than 50 percent share of the total short-acting EPO biosimilar market in Europe.
Biosimilars are alternatives to proprietary biopharmaceuticals, which are large-protein molecules derived from genetically modified cell lines. In contrast, "traditional" pharmaceuticals are made from small-molecule, chemical substances.
