The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.
News|Articles|August 26, 2026
FAQ: What FDA’s New Approach to Biosimilar Interchangeability Means for Developers
Author(s)Emily Schoenthaler
FDA's 2025–2026 guidance changes would substantially streamline biosimilar development, including by reducing comparative efficacy and switching-study requirements. Here's what's confirmed, what industry has criticized about the existing pathway, and what's still unresolved.
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FDA is proposing a significantly less burdensome path for biosimilar developers, with changes that could reduce several clinical studies historically used to support biosimilar and interchangeable biosimilar applications. The changes could lower development costs and timelines, but because the recommendations remain in draft form, important questions about how the revised framework will work in practice remain.¹,²
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