Implementing the BPCI Act: Many Challenges for the FDA
December 17, 2010
By: Janice A. Vatland
BNA Pharmaceutical Law & Industry Report
To increase access to biologic therapeutics and lower their cost, the Biologics Price Competition and Innovation Act ("BPCI Act") was enacted to create a pathway to obtain Food and Drug Administration (FDA) approval of generic versions of existing biologics based upon lesser showings of safety and efficacy than is required for a pioneer biologic. While the BPCI Act provides a framework for this pathway, how to implement it is up to the FDA.
