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119-s-1954119th CongressWALLET

Biosimilar Red Tape Elimination Act

Sponsored By: Senator Lee, Mike [R-UT]

In Committee

Summary

Clarifies when biosimilars are treated as interchangeable with their reference biologics. This bill would rewrite the biosimilar rules in section 351(k) to create a clear transition framework, preserve existing exclusivity, and force updated agency guidance to reflect the new rules.

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  • Manufacturers and applicants would see a restructured 351(k) pathway with consolidated application requirements and pared references to interchangeable labeling. This aims to standardize what information sponsors must submit.
  • Timing and market effects hinge on a defined transition date set at 60 days after enactment. Products licensed on or after that date would generally be deemed interchangeable at licensure. Products licensed before that date would become deemed interchangeable on the transition date. In both cases interchangeability is postponed if another product relying on the same reference biologic holds an active first‑interchangeable exclusivity.
  • The Food and Drug Administration would have deadlines to update guidance. The agency must revise interchangeability guidance and biosimilarity data guidance within 18 months and after public comment. The bill also narrows when a biosimilar can be treated as a new active ingredient by tying that finding to pediatric indication rules and to whether the product could be licensed under 351(k).

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 2 benefits, 0 costs, 0 mixed.

More biosimilars treated as interchangeable

This bill would treat many biosimilar drugs as interchangeable with their reference drug. The transition date is 60 days after enactment. Biosimilars licensed on or after that date would be interchangeable when licensed, unless they rely on the same reference drug as an earlier biosimilar that had a first-interchangeable exclusivity period in effect; then interchangeability would begin when that exclusivity ends. Biosimilars licensed before the transition date would become interchangeable on the transition date, except when blocked by an existing first-interchangeable exclusivity period that the bill preserves until it ends. If enacted, this would make it easier for pharmacists and insurers to substitute lower-cost biosimilars in many cases.

Simpler rules for biosimilar approvals

This bill would rewrite several legal phrases and cross-references for biosimilars to reduce ambiguity. It would also limit when a 351(k) biosimilar counts as having a new active ingredient for pediatric study rules. Under the new test, a biosimilar would be treated as a new active ingredient only if (1) the application seeks a pediatric indication already approved for the reference drug or has a deferred pediatric assessment, and (2) the pediatric study would require developing a product form, strength, route, or use that could not be licensed as a 351(k) biosimilar. These changes would apply on enactment to relevant applications and supplements.

Sponsors & CoSponsors

Sponsor

Lee, Mike [R-UT]

UT • R

Cosponsors

  • Sen. Luján, Ben Ray [D-NM]

    NM • D

    Sponsored 6/4/2025

  • Sen. Paul, Rand [R-KY]

    KY • R

    Sponsored 6/4/2025

  • Sen. Hassan, Margaret Wood [D-NH]

    NH • D

    Sponsored 6/4/2025

  • Sen. Schmitt, Eric [R-MO]

    MO • R

    Sponsored 6/24/2025

  • Sen. Ossoff, Jon [D-GA]

    GA • D

    Sponsored 6/16/2026

Roll Call Votes

No roll call votes available for this bill.

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