On July 18, 2025, the U.S. Food and Drug Administration (FDA) issued its finalized guidance on formal meetings related to biosimilar and interchangeable biologic product development. The 23-page document, released under the Biosimilar User Fee Act III (BsUFA III), outlines standardized procedures intended to make biosimilar development meetings more efficient, predictable, and collaborative.
This final guidance applies to both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). It builds upon previous guidance documents from 2018 and 2023, incorporating industry feedback and aligning with updated BsUFA III performance goals.
A Structured Framework for Formal Biosimilar Meetings
The FDA guidance categorizes formal biosimilar meetings into six types:
- Biosimilar Initial Advisory (BIA)
- Biological Product Development (BPD) Types 2a, 2b, 3, and 4
Each meeting type corresponds to a different stage of biosimilar development, ranging from early-stage advisory discussions to more detailed evaluations of clinical data and development strategies.
A key clarification in the final guidance is that a BIA meeting is not required before entering the BPD program. The BIA meeting is primarily intended for early-stage dialogue, allowing the FDA and the sponsor to discuss the proposed product in general terms, rather than conduct a substantive review of data. For sponsors seeking detailed feedback on clinical or comparative data, the FDA recommends pursuing a more advanced BPD meeting type.
Key Updates from the Draft Guidance
Compared to the 2023 draft, the finalized guidance introduces several important updates:
- Clarifies that requesting a BIA meeting is optional
- Expands on expectations for in-person meetings, including the role of core and non-core attendees
- Sets a cap of 10 questions per meeting request, including sub-questions
- Provides additional detail about what information sponsors should include when requesting a meeting
Notably, the FDA emphasized that while the meeting objectives and agenda help set the overall context, the specific list of questions is the most critical component for guiding discussion. Each question should be focused, well-explained, and relevant to the development stage of the product.
Meeting Best Practices and Sponsor Expectations
The guidance outlines best practices for sponsors to maximize the value of formal meetings:
- Clearly state the development stage of the biosimilar or interchangeable product
- Identify specific topics requiring FDA input
- Submit a list of attendees and clearly designate core participants
- Include a concise list of no more than 10 precise questions, each with context
For in-person meetings, the agency notes that virtual participation may be permitted for non-core attendees. However, all core participants, including key FDA staff and sponsor representatives, should attend in person when feasible to ensure productive face-to-face dialogue.
Implications for Biosimilar Sponsors
The finalization of this guidance offers biosimilar sponsors increased transparency and predictability in their interactions with the FDA. By outlining expectations for meeting format, scope, and timelines, the agency aims to reduce miscommunication and streamline the regulatory review process. This is particularly important as the U.S. biosimilar market continues to expand, offering lower-cost alternatives to biologics and improving patient access to critical therapies.
At EMMA International, we assist biosimilar developers with FDA meeting preparation, regulatory strategy, and compliance across every stage of product development. A clear, effective engagement with the FDA can significantly reduce delays and uncertainty, making expert guidance essential to navigating these formal interactions.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Hayes, E. (2025, July 18). FDA finalizes guidance for efficient biosimilars meetings, per BsUFA III. Regulatory News.
