Hospira Inc. presented two studies that demonstrate the pharmacokinetic and pharmacodynamic equivalence of its proposed biosimilar Epoetin Hospira. The U.S. Food and Drug Administration has conditionally approved the name Retacrit for the drug. Hospira submitted a Biologics License Application (BLA) to the FDA for Retacrit in December 2014.
These study data were presented at the National Kidney Foundation 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, MD, corporate vice president and chief medical officer of Hospira. "These studies contribute to the demonstration of biosimilarity and are an integral part of the overall biosimilar development program."
On March 30, Hospira launched the rheumatoid arthritis drug Inflectra in Canada, the country's first available biosimilar. The drug also treats ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
About the studies
Both randomized, open-label, active-controlled studies evaluated the pharmacokinetic and pharmacodynamic equivalence of proposed biosimilar Epoetin Hospira compared to Amgen's reference product, Epogen (epoetin alfa), administered by subcutaneous injection in healthy volunteers.
One study evaluated a single dose of 100 Units/kg, and the other study 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 pharmacodynamic clinical markers of reticulocyte count and hemoglobin, which were equivalent between Epoetin Hospira and Epogen in both studies. These markers were selected because they are directly reflective of the mechanism of action of epoetin alfa and, based on literature, are known to directly correlate with clinical effects.