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Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial |
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| Authors: | Fritz Sörgel Ursula Thyroff-Friesinger Andrea Vetter Bernhard Vens-Cappell Martina Kinzig |
| Institution: | 1. IBMP-Institute for Biomedical and Pharmaceutical Research, Nürnberg, Germany 2. Clinical Research, Hexal AG, Holzkirchen, Germany 3. Scope International, Hamburg, Germany |
| Abstract: | BackgroundHX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway. Therefore, in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa, the pharmacokinetic and pharmacodynamic response to steady state circulating concentrations of HX575 and a comparator epoetin alfa were compared following multiple intravenous administrations. |
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