New Era for Biosimilar Development: FDA Issues Finalized Meeting Guidance
The U.S. Food and Drug Administration (FDA) has rolled out comprehensive, finalized guidance to modernize how biosimilar developers and regulators communicate during the product development lifecycle. This pivotal document—replacing the 2023 draft—aims to clarify key procedures and help sponsors more efficiently navigate the biosimilar approval process under the Biosimilar User Fee Act III (BsUFA III).
Expanding Support for Biosimilars and Interchangeables
Targeted specifically at biosimilar and interchangeable biological products regulated by the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the guidance defines processes and expectations for six distinct meeting types. These meetings are instrumental for resolving scientific, safety, and regulatory issues as companies develop complex biologic medicines.
Biologics are among the most advanced medical products available, but their complexity makes development challenging. Efficient, transparent communication with the FDA is essential for bringing lower-cost biosimilar options to patients.
Six Meeting Types Define Structured Communication
1. Biosimilar Initial Advisory (BIA) Meeting
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An introductory session to determine pathway feasibility for a biosimilar development program.
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Analytical comparison of biosimilar and reference product is recommended but not required.
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One BIA meeting per program; no fee is charged.
2. BPD Type 1 Meeting
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Solves urgent or stalled development issues such as clinical holds or significant safety questions.
3. BPD Type 2a Meeting
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Focused on one or two technical issues, usually requiring input from three or fewer disciplines.
4. BPD Type 2b Meeting
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Broader scope with review of summary data, guiding sponsors on key program elements.
5. BPD Type 3 Meeting
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In-depth discussions involving comprehensive data review to evaluate biosimilarity claims.
6. BPD Type 4 Meeting
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Presubmission session to ensure application package completeness and identify potential review issues.
Flexible Meeting Formats and Faster Timelines
Reflecting pandemic-era digital transformation, the FDA’s new guidance offers four meeting modes:
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In-person (with virtual participation),
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Virtual (videoconference),
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Teleconference,
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Written Response Only (WRO) for some meeting types.
FDA response times—ranging from 14 to 21 days to acknowledge a meeting request—and defined timeframes for holding meetings (30–120 days, depending on type) mark a commitment to predictability and speed.
Lower Fees Benefit 2024 Developers
Significantly, BsUFA III introduces a much lower financial bar for companies entering the biosimilar pipeline:
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Initial and annual Biosimilar Biological Product Development (BPD) fees for 2024 are $10,000 (down from $47,325 in 2023).
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Reactivation fees are $20,000 (down from $94,650).
Prompt payment remains essential, as missed fees can result in meeting cancellations.
Clarity and Transparency: Meeting Package and Follow-Ups
Developers must submit detailed meeting packages—except for BPD Type 4 meetings, where these can be filed within 14 days post-request. Packages should include drug and reference product information, summarized development history, proposed questions (limited to 10), and supporting data.
To further enhance clarity, sponsors now have 20 calendar days after formal meeting minutes to submit clarifying questions, with the FDA responding in another 20 days.
Meeting conduct guidelines prohibit recordings and require brief, pre-approved presentations, with all outcomes documented in official FDA minutes or written responses.
Industry Impact: A Boost for Patient Access and Innovation
These updated protocols, including a new, streamlined Type 2a meeting and expanded digital meeting options, reinforce the FDA’s intent to demystify biosimilar drug development. By lowering costs, establishing clear communication channels, and offering predictable timelines, the agency hopes to foster greater innovation and bring more cost-effective biosimilar treatments to market faster—ultimately benefiting both patients and industry.
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