Biosimilar Red Tape Elimination Act
The Biosimilar Red Tape Elimination Act would upend the current path to interchangeable status by treating every biosimilar licensed under the 351(k) pathway as interchangeable with its reference product, rather than requiring a separate agency determination. A transition period of 60 days after enactment creates a phased change: products licensed on or after the transition date are deemed interchangeable upon licensure (with a narrow exception tied to ongoing first-interchangeability exclusivity), while products licensed before the transition date become interchangeable on the transition date, unless exclusivity applies. Importantly, the act preserves existing first-interchangeability exclusivity for pre-enactment products for the full duration of that period. The bill also harmonizes related statutes (FDA and PHS Act provisions) to remove the need for separate “interchangeable” labeling or determinations, and to require updated guidance from the Secretary of Health and Human Services within 18 months. In addition to changing how interchangeability is established, the bill broadens how biosimilars are treated for purposes of FDA approvals (e.g., removing references to “interchangeable biosimilar” in some places) and adjusts the “new active ingredient” considerations under the Hatch-Waxman framework for biosimilars. The Secretary would also issue updated and revised guidance within 18 months to reflect these changes, including data and information requirements to support a determination that a biosimilar is biosimilar to its reference product.
Key Points
- 1Interchangeability deemed upon licensure: Under the bill, a biosimilar approved under the 351(k) pathway would be considered interchangeable with its reference product at the time of licensure, subject to an exception related to existing first-interchangeability exclusivity.
- 2Transition date and its effects: A transition date is defined as 60 days after enactment. Licenses issued on or after this date are interchangeable upon licensure unless affected by an ongoing exclusivity period; licenses issued before this date become interchangeable on the transition date, again subject to any exclusivity.
- 3First interchangeable exclusivity preserved: For products with an unexpired first-interchangeability exclusivity period under prior law, that exclusivity remains in effect for its full duration.
- 4Conforming amendments across related laws: The bill amends several provisions in the Public Health Service Act and the FDA’ s and FDA-related statutes to remove references to separate interchangeability determinations and interchangeable designations, aligning them with the deeming approach.
- 5Secretary’s guidance and timelines: The Secretary must update and issue guidance within 18 months to reflect the changes, including revising prior guidance on demonstrating interchangeability and the data required to support biosimilarity and interchangeability, and then issue revised drafts or final versions after a public comment period.