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Clinical Data Shows Proposed Biosimilar, Epoetin Hospira, Demonstrates Pharmacokinetic and Pharmacodynamic Equivalence to Amgen's Epogen
PR Newswire (03/27/15)
Hospira, Inc. has presented two studies that support the biosimilarity of its proposed biosimilar, Epoetin Hospira (with the conditionally approved name Retacrit), compared with the reference product, Amgen's Epogen (epoetin alfa). The two randomized, open-label, active-controlled studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Epoetin Hospira compared with Epogen, injected in healthy volunteers. One study evaluated a single dose of 100 units/kg, while the second study evaluated multiple doses of 100 units/kg administered three times per week for four weeks. The results demonstrated the PD and PK equivalence of Epoetin Hospira and Epogen in the volunteers after multiple subcutaneous doses. The Biologics License Application for Epoetin Hospira was submitted to the Food and Drug Administration in December 2014. The study data were presented at the spring meeting of the National Kidney Foundation.
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