Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable products regulated under the Biosimilar User Fee Act (BsUFA) was published in June 2018. It describes the good meeting management practices (GMMPs) and the standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.

Types of Meetings

Various types of formal meetings occur between applicants or sponsors and the FDA to discuss development and review of a biosimilar or interchangeable product (as summarized in Table 1). The type of requested meeting will depend on the stage of development of the biosimilar or interchangeable product and on the type advice being sought. Typically, a sponsor is granted one Biosimilar Initial Advisory (BIA) meeting and one Biosimilar Biological Product Development (BPD) Type 4 meeting for a single biosimilar or interchangeable product. However, a sponsor may request as many BPD Type 2 and Type 3 meetings as needed. These meetings can take place as face-to-face, teleconference or videoconference, and written response only (WRO) formats of communication. WRO meetings can only be requested for BIA and BPD Type 2 meetings.

Table 1           Formal Meeting Types between the FDA and Sponsor of BSuFA Products

Name of MeetingObjectiveDetails of Meeting Type
Biosimilar Initial Advisory meetingTo discuss whether licensure under Section 351(k) of the PHS Act may be feasible for a particular product·         Meeting package should include: (a) preliminary comparative analytical similarity data from a particular biosimilar or interchangeable product compared to the reference product (b) an overview of the development program with the synopses of all completed, ongoing, and future studies ·         This meeting type is not for discussions involving significant review of summary data or full study reports
BPD Type 1To discuss how to address a stalled development program or an important safety issue·         Examples of topics to discuss include: (a)    Input on how to address the hold issues should be seek from the FDA when a clinical hold is in place. (b)   A new path forward needs to be discussed when the applicant has submitted the response to clinical hold issues and the response has been reviewed by the FDA but both the FDA and the sponsor agree that the development is stalled. (c)    Input on how to address issues from the FDA upon receipt of an FDA nonagreement Special Protocol Assessment letter (d)   Important safety issues (e)    Dispute resolutions as described in 21 CFR 10.75 and 312.48
BPD Type 2To discuss a specific issue so that FDA will provide advice with regards to an ongoing development program·         Meeting package may include significant review of summary data, but does not include full review of study reports
BPD Type 3To discuss an ongoing development program·         This meeting type includes full review of study reports or in-depth data review ·         FDA advice with regards to the similarity between a particular biosimilar of interchangeable product and the reference product ·         FDA advice with regards to the need for additional studies including their design and analysis
BPD Type 4To discuss content and format of a complete application or supplement submitted under Section 351(k) of the PHS Act·         A pre-submission meeting for a biosimilar or interchangeable product application

BPD = Biological Product Development; BSuFA = Biosimilar User Fee Act; CFR = Code Federal Regulation; PHS = Public Health Service Act

Planning an Effective Meeting

To have an effective meeting with the FDA, adequate information should be included in the meeting request. Sponsors or meeting requesters are encouraged to consult the information that are publicly made available by the FDA with regards to biosimilar or interchangeable product development and other relevant FDA guidance when planning, developing, and providing information needed to support a meeting with the FDA. Deviations of a product development plan from the current practices or guidance should be recognized and explained. In the meeting package, sponsors or requesters should define the specific areas of input needed from the FDA, which include the objectives of the meeting, the meeting agenda, list of questions for the FDA, list of attendees representing the sponsors, and list of FDA attendees.

Where to Submit Materials

A sponsor has to submit a written meeting request to the FDA through paper submission or via the electronic gateway, as applicable. Meeting requests should be directed to the appropriate review division or office. If previously assigned, a meeting request should be submitted to the pre-investigational new drug file (pre-IND) file or application. A meeting request for the development of a biosimilar or interchangeable product with multiple indications that requires multiple division reviews, should be addressed to the division that has the regulatory oversight of the reference product. The Center for Drug Evaluation and Research (CDER) prefers for copies of the meeting packages to be submitted in electronic and paper format, whereas the Center for Biologics Evaluation and Research (CBER) prefers for copies of the meeting packages to be submitted only in electronic format.

What to Expect After Submitting a Meeting Request to the FDA

Upon receiving a meeting request, the FDA assesses each request and determines whether or not the request will be granted. The FDA will specify the meeting type and format of communication. The FDA will notify the sponsor or requester in writing the decision for the requested meeting within 14 days of BDP Type 1 meeting or 21 days for BIA and BDP Types 2, 3, and 4 meetings. Notification from the FDA usually includes the date, time, conferencing arrangements or location of the meeting, and the expected FDA attendees for the face-to-face and the teleconference or videoconference meetings. For WRO meeting requests, BIA and BDP Types 1, 2, 3, and 4 meetings are scheduled within 75 days, 30 days, 90 days, 120 days, or 60 days, respectively, from receipt of WRO meeting package. For BIA and BDP Type 2 WRO meetings, the response time are within 75 days and 90 days, respectively, from receipt of WRO meeting request and package.

Reasons the FDA Denies or Cancels a Meeting Request

Requests for BPD Types 2, 3, and 4 meetings are usually granted except in the most unusual circumstances. However, the FDA will deny a meeting request for any of the following reasons:

  • The meeting request is not in an appropriate format
  • The meeting request is considered by the FDA as incomplete (i.e., the request is not accompanied with a meeting package containing adequate information for FDA review)
  • Failure to pay the required BPD fees for a biosimilar or interchangeable product within the required time frame, may result in the cancellation of a scheduled meeting.

BsUFA Fees

Under the BsUFA user fee provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), BDP fees are applied to biosimilar or interchangeable products in the BDP program. There is no fee associated with a BIA meeting. BDP fees include the initial, annual, and reactivation fees. Sponsors are encouraged to review the draft guidance of Assessing User Fees under the Biosimilar User Fee Amendments of 2017 to obtain more information related to BsUFA fees.

How to Handle Preliminary Responses from the FDA

Communications between the FDA and sponsors that take place before the formal meeting may serve as the foundation for the discussion during the meeting. However, preliminary responses from the FDA should not be considered as final responses unless there is an agreement that further discussions are not required. In addition, new information and questions should not be generated based on the preliminary responses from the FDA. Preliminary responses are sent to the sponsors or requesters no later than 5 calendar days before the face-to-face, teleconference, or videoconference meeting date for BDP Types 2 and 3 meetings. For other meeting types, preliminary responses are sent no later than 2 calendar days before the face-to-face, teleconference, or videoconference meeting.

The Formal Meeting

Formal meetings are chaired by an FDA staff. The meetings usually start with introductions and an overview of the agenda. Formal presentations during the meetings are usually not required because adequate information should have been provided in the meeting package. However, if a presentation is necessary, it should be discussed ahead of time with the FDA project manager, who will determine whether a presentation will take place during the meeting. Additionally, presentation materials should be submitted ahead of the scheduled meeting. Meeting summaries can be generated by an FDA or a sponsor attendee. However, the FDA’s meeting minutes are the official records of meetings and have to be preserved for meeting attendees and future reference. The FDA generally issue the official meeting minutes to the sponsors or meeting requesters within 30 calendar days after the meeting.

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