On January 6, the U.S. Food and Drug Administration (FDA) released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity.

Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars and how interchangeability will be determined.

The titles of the forthcoming biosimilarity guidances will be as follows:

  1. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  2. Considerations in Demonstrating Interchangeability to a Reference Product
  3. Labeling for Biosimilar Biological Products
  4. Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

The full 2015 CDER Guidance Agenda may be read here.