On May 31, 2018, FDA issued draft guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Biosimilar User Fee Act (BsUFA) Products. The draft guidance provides background indicating that, each year, FDA review staff holds many formal meetings with sponsors seeking advice regarding the development and review of biosimilar or interchangeable products regulated by the CDER or the CBER. Because these formal meetings often represent critical points in the regulatory and development process, the draft guidance seeks to provide recommendations to sponsors on how to hold formal meetings with the FDA regarding the development and review of biosimilar or interchangeable products. Specifically, the guidance discusses the principles of good meeting management practices (GMMPs) and describes consistent, standardized procedures that promote well-managed meetings and ensures that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately.

The draft guidance identifies the five types of formal meetings that occur between sponsors and FDA staff to discuss a biosimilar or interchangeable product and describes important procedures for each meeting:

  • Biosimilar Initial Advisory (BIA) is an initial assessment limited to a general discussion regarding whether licensure under section 351(k) of the PHS Act may be feasible for a particular product. For BIA meetings, the draft guidance recommends that preliminary comparative analytical similarity data from at least one lot of the proposed biosimilar or interchangeable product compared to the U.S.-licensed reference product should be provided in the meeting package.
  • Biosimilar Biological Product Development (BPD) Type 1 includes meetings to discuss clinical holds, meetings that are requested after receipt of an FDA nonagreement Special Protocol Assessment letter, meetings to discuss an important safety issue, and dispute resolution meetings.
  • BPD Type 2 includes meetings to discuss a specific issue such as ranking of quality attributes, manufacturing, study design or endpoints, etc. This meeting may include substantive review of summary data.
  • BPD Type 3 is an in-depth data review and advice meeting regarding an ongoing development program and should include substantive review of full study reports or an extensive data package.
  • BPD Type 4 is a presubmission meeting to discuss the format and content of a complete application for an original biosimilar or interchangeable product application and should include (1) identification of studies that sponsor is relying upon to support biosimilarity or interchangeability, (2) discussion of any potential review issues, (3) status of studies related to the Pediatric Research Equity Act, (4) general information to be submitted in the marketing application, and (5) discussion of presentation and formatting of data in the marketing application.

The draft guidance further discusses general considerations for holding formal meetings with the FDA including describing BsUFA fees associated with the formal meetings, describing meeting formats via face to face, teleconference/videoconference, or written response only, outlining procedures to request a meeting with the FDA, detailing procedures for denying and granting meetings, specifying communications before meetings, rescheduling meetings, cancelling meetings, guidelines for meeting conduct, and general considerations regarding documentation of meeting minutes.

The draft guidance further outlines meeting package content requirements to facilitate FDA review. For example, the guidance recommends that the meeting package should provide information relevant to the product, stage of development, and meeting type requested. The guidance further recommends that the meeting package contain enough detail to meet the meeting objectives, e.g., inclusion of raw data to support the derived conclusions in the package. The guidance further warns that simply describing a result as “significant” without support is insufficient information for the FDA review division to give good advice or identify important problems the sponsor may have missed. The guidance finally lists sixteen pieces of information such as application number and proposed indications that should be included in each meeting package.

Readers are encouraged to read the draft guidance, also available on FDA’s website.