Hospira, Inc. presented two studies supporting biosimilar application for Epoetin Hospira in the US.
Hospira, a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies at the National Kidney Foundation (NKF) Spring Meeting.
The two presentations were “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 support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the US Food and Drug Administration (FDA) conditionally approved name of Retacrit, compared to the reference product, Amgen’s Epogen (epoetin alfa).
In the US, Epogen is approved to treat anemia caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
Both of the studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Epoetin Hospira compared to Amgen’s Epogen administered by subcutaneous injection in healthy volunteers. One study tested a single dose of 100 units/kg, and the other evaluated multiple doses of 100 units/kg administered three times per week for a total of four weeks. The studies included measuring the effect of well-established PD clinical markers of reticulocyte count and hemoglobin. These measures were chosen because they are directly reflective of the mechanism of action of epoetin alfa and are known to directly correlate with clinical effects.
“Both studies are consistent with the assessment of biosimilarity between the reference product, Epogen, and the Hospira proposed biosimilar, Epoetin Hospira,” said Stan Bukofzer, MD, 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 program.”
Hospira, which has agreed to be bought by Pfizer for a value of $17 billion, said that it has already filed a Biologics License Application (BLA) for Epoetin Hospira to the US Food and Drug Administration (FDA), under the new approval pathway created by the Biologics Price Competition and Innovation Act (BPCIA).
Source: Hospira, Inc.
Last updated: 3/27/14; 2:25pm EST