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USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

Today (11 August 2023) the United States Food & Drug Administration released a draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products” and guidance "Classification Categories for Certain Supplements Under BsUFA III".

Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

This guidance provides recommendations to the industry on how to conduct formal FDA meetings with sponsors or applicants regarding the development and approval of biosimilars and interchangeable biosimilars under the direction of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings including meetings conducted in any format (i.e., in-person, virtual (videoconference), teleconference, or written response only (WRO)).

There are six types of formal meetings that occur between requesters and FDA staff to discuss the development and review of a biosimilar or interchangeable biosimilar product:

  1. BIA,

  2. BPD Type 80 1,

  3. BPD Type 2a,

  4. BPD Type 2b,

  5. BPD Type 3, and

  6. BPD Type 4.

Before seeking a meeting with the FDA, requesters should review the information publicly available from the FDA about the development of biosimilar or interchangeable biosimilar products.

Guidance: Classification Categories for Certain Supplements Under BsUFA III

The guidance provides recommendations on the classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements, as defined in section 351(k) of the Public Health Service Act. his guidance is intended to help applicants identify the appropriate classification category and review the goal date of the supplement being submitted.

Biosimilar and interchangeable biosimilar product supplements are classified into the following categories:

  • To update Prescribing Information and, if applicable, FDA-approved patient labeling (e.g., Patient Package Insert, Medication Guide, Instructions for Use) with safety information that has been updated in the reference product labeling and is applicable to one or more indications for which the biosimilar or interchangeable biosimilar product is licensed

  • To receive licensure for an additional indication

  • To remove an approved indication

  • To receive an initial determination of interchangeability

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