Biosimilars US Food and Drug Administration Commissioner Scott Gottlieb announced in a statement that the FDA has released two guidance documents to facilitate implementation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as well as a proposed rule that provides FDA’s interpretation of the terms “protein” and “chemically synthesized polypeptide” in the statutory definition of “biological product.” 12 December 2018