Biosimilar Red Tape Elimination Act
Sponsored By: Representative Pfluger
Introduced
Summary
Deems many biosimilars interchangeable with their reference biologics under a new 60-day transition framework while preserving first-interchangeable exclusivity. It would reorganize the 351(k) approval rules and require the FDA to issue updated guidance within 18 months.
Show full summary
- Patients and prescribers: A biosimilar licensed on or after the transition date would generally be treated as interchangeable at licensure, or become interchangeable on the transition date if licensed earlier. The transition date is 60 days after enactment.
- Biologic manufacturers: The bill preserves any unexpired "first interchangeable" exclusivity for its remaining term and delays deemed interchangeability for other products that rely on the same reference product until that exclusivity ends.
- FDA and regulators: It tightens and renumbers the statutory 351(k) framework, simplifies interchangeability criteria, makes conforming edits to related law, and requires updated or new guidance on interchangeability and biosimilarity within 18 months of enactment.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Faster biosimilar substitutions for patients
If enacted, most FDA-licensed biosimilars would be treated as interchangeable with their brand-name reference drug. Biosimilars licensed before the transition date would become interchangeable on that date, which is 60 days after enactment. Biosimilars licensed on or after that date would be interchangeable at approval. If another product already has a first-interchangeable exclusivity for the same reference drug, interchangeability would wait until that exclusivity ends; existing exclusivity would be preserved. FDA would still require enough data to prove biosimilarity. Patients who use biologic drugs could see more pharmacy substitution and possibly lower out-of-pocket costs, depending on plan and pharmacy policies.
Clearer FDA rules for biosimilars
If enacted, FDA would update and issue biosimilar guidance within 18 months. The agency would revise its 2019 and 2024 interchangeability guidances and spell out what data applicants must submit. Revised drafts or final versions would be due within 18 months after each comment period closes. The bill would also narrow when a biosimilar counts as a “new active ingredient” for pediatric review. It would count only if both: the application seeks a pediatric use already tied to the reference product (or one with a deferred pediatric study), and the pediatric work would not require a strength, form, route, or use that cannot be licensed through the biosimilar pathway.
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Sponsors & CoSponsors
Sponsor
Pfluger
TX • R
Cosponsors
Landsman
OH • D
Sponsored 9/19/2025
Rep. Auchincloss, Jake [D-MA-4]
MA • D
Sponsored 10/17/2025
Crenshaw
TX • R
Sponsored 11/10/2025
Rep. Vasquez, Gabe [D-NM-2]
NM • D
Sponsored 12/9/2025
Owens
UT • R
Sponsored 2/4/2026
Rep. Fine, Randy [R-FL-6]
FL • R
Sponsored 3/9/2026
Roll Call Votes
No roll call votes available for this bill.
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