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BioPharmaceutical Europe

EPO “Follow-On” Products In Europe Need Two Clinical Efficacy Trials, EMEA Says

This article was originally published in The Pink Sheet Daily

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Executive Summary

European Medicines Agency draft guidance on registration requirements for biosimilar epoetin products says efficacy studies should include a “maintenance phase” and a “titration phase.” The guidelines also call for clinical safety data from at least 300 patients.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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