USA – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

This guidance is intended to assist sponsors who are developing biological products, sponsors of biologics license applications (BLAs), and other interested parties in providing information that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Under 351(k)(7), licensure of an application for a biosimilar or interchangeable product under 351(k) of the PHS Act (also known as a 351(k) application) may not be made effective by FDA until the date that is 12 years after the date on which the reference product referred to in the 351(k) application was first licensed under section 351(a) of the PHS Act. In addition, a 351(k) application may not be submitted to FDA for review until 4 years after the date of first licensure of the reference product. This period of time in which a 351(k) application may not be licensed (or submitted for review) is known as the reference product exclusivity period. Thus, a decision under 351(k)(7)(C) regarding the date of first licensure of a reference product submitted under 351(a) is, in effect, a decision on eligibility for reference product exclusivity and on the date on which such exclusivity begins to run…