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

Sharan Murugan
Jul 19
3 min read

In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This procedural document, released under the Biosimilar User Fee Act (BsUFA) III, offers sponsors practical instructions and expectations when engaging with FDA review staff during the development of biosimilars and interchangeable biosimilars regulated by CDER and CBER.

This guidance standardizes how sponsors and FDA coordinate meetings about biosimilars (licensed under section 351(k) of the Public Health Service Act). It covers:

Biosimilars and interchangeable products
Products under CDER (drugs) and CBER (biologics)
Formal meetings requested by sponsors at all stages of development

The guidance does not cover:

New drug applications (NDAs)
Full biologics license applications under section 351(a)
Medical device submissions

The FDA outlines six formal meeting types, each tailored to a stage or purpose:

Meeting Type	Purpose	Key Notes
BIA (Biosimilar Initial Advisory)	Early feasibility discussion on licensure as a biosimilar	Does not involve full data review
BPD Type 1	Resolve stalled programs, address clinical holds or critical safety issues	Often urgent
BPD Type 2a	Narrow focus (1–2 topics) needing ≤3 disciplines	Requires prior BIA or BPD meeting
BPD Type 2b	Targeted advice on specific issues; includes summary data but not full reports	Broader scope than 2a
BPD Type 3	In-depth scientific review of data sets & full study reports	Used for analytical similarity or major clinical data
BPD Type 4	Presubmission meeting on BLA content, format, and strategy	Helps align final filing plans

These meeting types are matched with FDA’s performance goals under BsUFA III, providing sponsors clarity on timelines.

Meeting Formats

Meetings can be conducted in various formats to suit the type and complexity of the discussion:

In-person (face-to-face)
Virtual (videoconference)
Teleconference (audio only)
Written Response Only (WRO): Available for certain meeting types (BIA, BPD Type 2a, Type 2b)

Choice of format will be determined by the FDA based on the nature of the requested feedback and meeting objectives.

Requesting a Meeting

The guidance details a precise process:

Use FDA electronic systems (e.g., eCTD, Electronic Submissions Gateway)
Include application number (if assigned), product name/structure, proposed indications, pediatric study plans, and combination product details
Provide:
- Purpose & rationale
- Agenda with timing estimates
- Precise list of ≤10 questions, grouped by FDA discipline, each with context
- Proposed meeting format (face-to-face, virtual, teleconference, or written response only)

FDA stresses that well-structured questions and background data are essential; poorly defined questions risk denial or delay. The FDA will respond to meeting requests and schedule meetings within prescribed timeframes based on the meeting type.

If a meeting is granted, confirmation includes date, time, expected participants, and teleconference details (if applicable).
For Written Response Only (WRO) Requests, the FDA provides a date for written responses.

Meeting Package

For most meetings, a background package is required at the time of request. Essential elements:

Product history and status of development.
Justification and supporting data for requested advice.
Specific issues for FDA input, with cross-referenced supporting materials.
Proper organization (pagination, table of contents, bookmarks) to facilitate FDA review.

This package must provide sufficient detail to allow meaningful discussion and FDA preparation.

Fees

BsUFA user fees apply to products in the development program: initial, annual, and reactivation fees.
There is no fee for BIA meetings.
Failure to pay required fees may result in meeting cancellation

During meetings:

No recording devices are allowed
Presentations should be brief, using data already submitted
Summaries by sponsor and FDA clarify agreements & next steps

Minutes: FDA issues official minutes within 30 days. Sponsors can correct factual errors but not reinterpret discussion.

Follow-up: Sponsors can ask clarifying questions (not new proposals) within 20 days of minutes; FDA responds within 20 days.

For complete details and templates, sponsors should consult the full FDA guidance: LINK

Also USFDA released 2 draft guidances this week and click the below links to know more in detail