What Statutes and Regulations Govern the Approval and Marketing of Biosimilars?
What Statutes and Regulations Govern the Approval and Marketing of Biosimilars?
approval and marketing of biosimilars
Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in 2010 an amendment of the Public Health Services Act. The BPCIA is codified at 42 U.S.C. § 262.