The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an abbreviated approval pathway in the U.S. for biosimilar versions of previously approved therapeutic biologics. The proposed guidance, which was released on August 8, 2014, addresses the 12-year period of reference product exclusivity granted under section 351(k)(7) of the Public Health Service Act (“PHS Act”). Under Section 351(k)(7), the FDA may not grant licensure to an application for a biosimilar or interchangeable product under 351(k) of the PHS Act (“a 351(k) application”) 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, the FDA may not accept for review a 351(k) application until 4 years after the date of first licensure of the reference product. The BPCIA provisions make clear that not every licensure of a biologic under 351(a) is considered a “first licensure” giving rise to a 12-year period of exclusivity. The proposed guidance is intended to give 351(a) applicants, biosimilar applicants, and other interested parties direction as to what information the FDA will need to make a determination of the date of first licensure for a reference product.

The Guidance specifically recognizes the unique challenges in making such a determination in the context of biologics (as opposed to small molecule drugs). For example, the FDA notes the “scientific and technical complexities that may be associated with the larger and typically more complex structures of biological products as compared with small molecule drugs, as well as the processes by which such biological products are made.” (Guidance at 3.)