The FDA has delivered on its promise to issue guidance on interchangeability, opening the door to automatic pharmacy substitution and the closest thing possible to a generic biologic. In keeping with the 2010 Biologic Price Competition and Innovation Act (BPCIA), the draft guidance lays out a continuum that moves beyond biosimilarity through a stepwise approach to address residual uncertainty about how closely a would-be interchangeable matches up with the original U.S.-licensed biologic.

The FDA finalized its guidance on assessing the abuse potential of small-molecule drugs that affect the central nervous system (CNS). Proposed new drugs containing a substance with CNS activity likely will need to be thoroughly assessed for abuse potential, according to the guidance. That assessment, along with proposed scheduling under the Controlled Substances Act, should be included in the new drug application. The guidance also discusses recommended studies to assess the abuse potential of a drug.

The FDA launched its Oncology Center of Excellence Thursday, making cancer the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency's three medical product centers. The new center is expected to improve the FDA's ability to streamline stakeholder engagement and to advance oncology-related regulatory science and policy. While the review criteria and application requirements for oncology therapies and diagnostics will remain the same, the center will unite the agency's experts to collaborate on the clinical review of the products.