Hospira's Proposed Biosimilar, Epoetin Hospira, Demonstrates PK/PD Equivalence Compared to Amgen's Epogen

Hospira presented two studies that support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the FDA conditionally approved name of Retacrit, compared to the reference product, Amgen's Epogen (epoetin alfa). These study data were presented at the National Kidney Foundation (NKF) spring meeting in abstracts titled "PK/PD Equivalence of Epoetin Hospira and EPOGEN Following Single Subcutaneous Doses to Healthy Subjects," and "Epoetin Hospira and Epogen PK/PD Equivalence Following Multiple Subcutaneous Doses to Healthy Subjects."

"Both studies are consistent with the assessment of biosimilarity between the reference product, Epogen, and the Hospira proposed biosimilar, Epoetin Hospira," said Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira. "These studies contribute to the demonstration of biosimilarity and are an integral part of the overall biosimilar development programme."