Draft Guidance for Industry on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products is a draft guidance for industry that provides recommendations on meetings relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

The draft guidance describes five types of formal meetings that occur between requesters and FDA staff to discuss development and review of a biosimilar or interchangeable product:

  1. Biosimilar Initial Advisory is an initial assessment limited to a general discussion regarding whether licensure may be feasible for a particular biosimilar product and general advice on the expected content of the development program.
  2. Biosimilar Biological Product Development Type 1 is a meeting needed for an otherwise stalled development program to proceed or to address an important safety issue.
  3. Biosimilar Biological Product Development Type 2 is a meeting to discuss a specific issue (e.g., ranking of quality attributes, study design or endpoints) or questions for which the FDA will provide targeted advice regarding an ongoing development program.
  4. Biosimilar Biological Product Development Type 3 is an in-depth data review and advice meeting regarding an ongoing development program.
  5. Biosimilar Biological Product Development Type 4 is a presubmission meeting to discuss the format and content of a complete application for an original biosimilar or interchangeable product application or supplement.

This new draft guidance supersedes a previous guidance for industry titled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” published November 18, 2015.

The full document is available on the FDA website.