# 119-hr-9661: Expedited Access to Biosimilars Act

119-hr-9661, Expedited Access to Biosimilars Act, is a 119th Congress bill sponsored by Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY); status introduced; PRIA reads it as touching household money (as of 2026-08-02).

- Canonical: https://policyrisk.com/legislation/119-hr-9661
- As of: 2026-08-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-9661
- Congress: 119
- Title: Expedited Access to Biosimilars Act
- Status: introduced
- Introduced: 2026-07-14
- Sponsor: Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-08-02

## Summary

**This bill makes pharmacokinetics and immunogenicity the default evidence for biosimilar licensure instead of clinical pharmacodynamics or comparative clinical efficacy studies.** - 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.

## Cosponsors (2)

- Rep. Schrier, Kim [D-WA-8] (D-WA), 2026-07-14T00:00:00.000Z
- Rep. Wittman, Robert J. [R-VA-1] (R-VA), 2026-07-21T00:00:00.000Z

## Provisions PRIA read

- Limits FDA study requirements for biosimilars: benefit, medium. 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…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-4669: FEMA Act of 2025
- 119-hr-4206: CONNECT for Health Act of 2025
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-5509: Safe Step Act
- 119-hr-3277: Ensuring Lasting Smiles Act

## Sources
- [119-hr-9661 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/9661)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-4669: FEMA Act of 2025](https://policyrisk.com/legislation/119-hr-4669)
- [119-hr-4206: CONNECT for Health Act of 2025](https://policyrisk.com/legislation/119-hr-4206)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-5509: Safe Step Act](https://policyrisk.com/legislation/119-hr-5509)
- [119-hr-3277: Ensuring Lasting Smiles Act](https://policyrisk.com/legislation/119-hr-3277)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-9661 (as of 2026-08-02).