FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
By Zachary Brennan -
Published 03 January 2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Due Diligence, Government affairs
Tags: clinical pharmacology data, biosimilars, reference products, FDA guidance