This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the PHS Act and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar2 22 to or interchangeable with an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient 24 Protection and Affordable Care Act (Affordable Care Act) (Public Law 111-148)). Although the 351(k) pathway applies generally to biological products, this guidance focuses on therapeutic protein products and gives an overview of important scientific considerations in demonstrating interchangeability of a proposed therapeutic protein product (proposed interchangeable product or proposed product) with a reference product.
This guidance is one in a series of guidances that FDA is developing to implement the BPCI Act and includes references to information from other FDA guidances, where appropriate.