The US Approval Pathway for Biosimilar and Interchangeable Biological Products: Overview of the 2–3 November 2010 FDA Public Hearing

On 23 March 2010, President Obama signed into law the Patient Protection and Affordable Care Act. The law contains a subtitle entitled the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).1 "The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be 'highly similar' (biosimilar) to, or 'interchangeable' with, an FDA-licensed reference biological product."2