Expedited Access to Biosimilars Act
Sponsored By: Senator Paul, Rand [R-KY]
Introduced
Summary
Changes clinical-study rules for biosimilar approval. This bill would amend the Public Health Service Act (42 U.S.C. 262(k)) to let applicants use clinical study or studies that assess pharmacokinetics to show safety, purity, and potency, and to make other clinical assessments required only when the Secretary specifically determines and justifies them.
Show full summary
- Manufacturers and applicants: Would allow biosimilar licensure to rely on pharmacokinetic clinical studies rather than broader routine trials. The Secretary may still require tests for immunogenicity, pharmacodynamics, or comparative clinical efficacy, but only with written justification delivered by the earliest date an applicant may file.
- Patients and clinicians: Could reduce the clinical testing developers must do before filing, which may change how biosimilars are developed and brought to clinical use.
- Regulators: Preserves the Secretary's discretion to demand extra clinical assessments while adding an early-notice and written-justification rule. The changes would apply to 351(k) applications submitted on or after enactment.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
New biosimilar study and notice rules
If enacted, the bill would change clinical study rules for biosimilar drug applications. Applicants filing biosimilar applications on or after enactment would need pharmacokinetic studies that show safety, purity, and potency. They would also need clinical study(ies) sufficient to show safety, purity, and potency for at least one approved use. The Health Secretary could require extra tests like immunogenicity or comparative efficacy. But the Secretary could only require them after giving written notice and a written justification. That notice must come by the earliest date the applicant may file the application. These changes would apply to biosimilar applications filed on or after enactment.
Sponsors & CoSponsors
Sponsor
Paul, Rand [R-KY]
KY • R
Cosponsors
Sen. Lee, Mike [R-UT]
UT • R
Sponsored 6/3/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov