Biosimilar Formal Meetings Draft Guide

FDA has released a draft guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations to industry on formal meetings about the development and review of biosimilar or interchangeable biosimilar products. It discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting formal meetings.

Additionally, the draft guidance revises and replaces a 6/2018 draft under the same title. It has been revised to include:

• Changes to the data expectations in Biosimilar Initial Advisory meeting requests
• Addition of Biological Product Development (BPD) Type 2a meeting
• Changes to when the meeting background package is submitted for a BPD Type 4 meeting
• Changes to the description of the available meeting formats
• Addition of an option for a request for clarification