Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests.

As the Food and Drug Administration (FDA) continues to implement the hotly contested approval pathway for follow-on biologics established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the latest milestone came on August 5, 2014, when the Agency announced the availability of a new draft guidance document entitled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act. The draft guidance – which comes less than two weeks after the first public announcement that FDA has accepted a follow-on biologic application for filing – describes the information that sponsors should provide when requesting reference product exclusivity for biologic products and the principles that FDA will consider when reviewing such requests. This article highlights key points contained in the draft guidance and assesses their potential significance for biologic product manufacturers.

Originally Published in Pharmaceutical Law & Industry Report, 12 PLIR 1212 - August 22, 2014.