In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and “Classification Categories for Certain Supplements under BsUFA III”, respectively.
The “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” draft guidance is an update to the 2018 issued guidance of the same name, and proposes best practices for applicants to meet with relevant FDA entities in an efficient, uniform manner. The guidance provides information on the types of meeting available to biosimilar applicants, standardizes expectations with regards to questions and data for each type of meeting, and provides instruction on requesting meetings with relevant FDA entities. The updated 2023 guidance amends the previous guidance to add additional submission criteria for Biosimilar Initial Advisory (BIA) meeting requests; revises the types of Biological Product Development (BPD) meetings, and submission timelines for the meetings; amends allowable meeting formats to include virtual video conferencing; and adds an option to submit clarifying questions to the FDA.
The new “Classification Categories for Certain Supplements under BsUFA III” draft guidance explains how to identify the appropriate type of supplement to submit to a previously approved biosimilar application. The six types of prior approval supplements (listed as A-F) were previously defined in a commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) and pertain to efforts to update prescription information, add or remove a disease indication, or request an initial determination of interchangeability with an FDA-licensed product. The guidance states that the categorization “will help to ensure consistent processes for reviewing these supplements across review divisions”, and will provide readers with an overview of the six types of prior approval supplements (A: Safety Information; B: Additional Indication(s) Without New Data Sets; C: Removal of Indication(s); D: Additional Indication(s) With New Data Sets or Without New Data Sets But Subject To Section 505B(a) of the FD&C Act and Does Not Contain An Up-To-Date Agreed iPSP; E: Additional Indication(s) With Efficacy Data Sets; and F: Initial Determination of Interchangeability) and guidance on best practice for submitting supplements to the appropriate categories.
Both draft guidance are currently open for public comment with comments requested by October 10, 2023.