FDA issues new biosimilars guidance on exclusivity

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.”

The draft guidance is intended to assist sponsors developing biological products, sponsors holding Biologics License Applications (BLAs), and other interested parties in providing information and data 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).

The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.