Expedited Access to Biosimilars Act
Sponsored By: Representative Langworthy, Nicholas A. [R-NY-23]
Introduced
Summary
This bill makes pharmacokinetics and immunogenicity the default evidence for biosimilar licensure instead of clinical pharmacodynamics or comparative clinical efficacy studies.
Show full summary
- Developers: Sponsors can rely primarily on clinical pharmacokinetics and immunogenicity data when seeking biosimilar approval rather than new PD or comparative efficacy trials.
- Regulators: The Secretary may require additional clinical study only if those studies are necessary to demonstrate biosimilarity. The Secretary must provide written notice of that requirement by the date of a biosimilar development meeting or within 60 days after an application is submitted.
- Scope and structure: The bill reorganizes certain review subsections of section 351(k) of the Public Health Service Act and applies only to applications submitted on or after enactment.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Limits FDA study requirements for biosimilars
This bill would change what clinical data can be used to show a biosimilar is similar to a reference biologic. The Secretary would be able to accept pharmacokinetics and immunogenicity assessments, including clinical pharmacokinetics studies, as specified evidence. The Secretary would only be able to require extra clinical study(ies) in an approved use if the Secretary determines those studies are necessary together with other required studies, and must give the sponsor written notice either when granting a biosimilar development meeting (unless the Secretary explains why an assessment cannot be made) or within 60 days after the 351(k) application is filed. These rules would apply to 351(k) applications filed on or after the date of enactment and could speed biosimilar entry and lower drug costs over time.
Sponsors & CoSponsors
Sponsor
Langworthy, Nicholas A. [R-NY-23]
NY • R
Cosponsors
Rep. Schrier, Kim [D-WA-8]
WA • D
Sponsored 7/14/2026
Rep. Wittman, Robert J. [R-VA-1]
VA • R
Sponsored 7/21/2026
Roll Call Votes
No roll call votes available for this bill.
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