Submitted on July 24, 2014- USP's Comment Letter to the FDA on draft guidance Industry, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. This was related to the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act, Title VVII.A of Public Law 111-48). Docket No. FDA-2014-D-0234.
