FDA Draft Guidance Clarifies Meeting Types for Biosimilar Applicants

This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.

There are 5 different meeting types that can take place between the FDA and sponsors or applicants related to the development of biosimilar or interchangeable products:

• Biosimilar Initial Advisory (BIA) Meeting. This meeting is meant to be a general discussion of whether licensure under section 351(k) of the Public Health Service (PHS) Act would qualify for a particular product, and if so, the agency will provide an overview of the content expected from the manufacturer’s development program.
• Biosimilar Biological Product Development (BDP) Type 1 Meeting. This meeting is necessary for a development program that is stalled or if an important safety issue needs to be addressed. For example, this could be a post-action meeting that was requested after the FDA issued a regulatory such as a Complete Response Letter.

• BDP Type 2 Meeting. This meeting is meant to discuss a specific issue, including chemistry, manufacturing, study design, or endpoints. This type of meeting may also include a substantive review of summary data, but it does not include a review of full study reports.
• BDP Type 3 Meeting. During this meeting, a substantive review of full study reports or an extensive data package will be conducted. The FDA will also offer advice regarding the similarity between the proposed biosimilar or interchangeable product and the reference product.
• BDP Type 4 Meeting. This meeting is meant to be a pre-submission meeting to discuss the format and content of a complete application for a biosimilar or interchangeable product (or a supplement submitted under the 351[k] pathway of the PHS Act).

With the publication of this draft guidance, the FDA has also noted that previous related guidance named “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” issued in November 2015, is withdrawn.

The FDA is requesting comments on the draft guidance until September 4, 2018.