FDA Plans to Release Biosimilarity Guidances in 2016

Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity:

  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Labeling for Biosimilar Products
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

We will continue to monitor the release of these guidances on Big Molecule Watch.