# 119-hr-10628: Biosimilars Access and Affordability Act

119-hr-10628, Biosimilars Access and Affordability 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 2026-10-24).

- Canonical: https://policyrisk.com/legislation/119-hr-10628
- As of: 2026-10-24
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-10628
- Congress: 119
- Title: Biosimilars Access and Affordability Act
- Status: introduced
- Introduced: 2026-09-28
- Sponsor: Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY)
- Cosponsors: 9
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-10-24

## Summary

**Creates a two-year delay framework for biosimilars in Medicare drug-price negotiations.** The bill would tie when a biological product becomes a "selected drug" to the negotiation list's publication date and add new evidentiary and verification steps for delaying price limits.

## Cosponsors (9)

- Rep. Auchincloss, Jake [D-MA-4] (D-MA), 2026-09-28T00:00:00.000Z
- Rep. Joyce, John [R-PA-13] (R-PA), 2026-09-28T00:00:00.000Z
- Rep. Sánchez, Linda T. [D-CA-38] (D-CA), 2026-09-28T00:00:00.000Z
- Rep. Peters, Scott H. [D-CA-50] (D-CA), 2026-09-28T00:00:00.000Z
- Rep. Yakym, Rudy [R-IN-2] (R-IN), 2026-09-28T00:00:00.000Z
- Rep. Moran, Nathaniel [R-TX-1] (R-TX), 2026-09-28T00:00:00.000Z
- Rep. Mullin, Kevin [D-CA-15] (D-CA), 2026-09-28T00:00:00.000Z
- Rep. Panetta, Jimmy [D-CA-19] (D-CA), 2026-09-28T00:00:00.000Z
- Rep. Davis, Donald G. [D-NC-1] (D-NC), 2026-10-22T00:00:00.000Z

## Provisions PRIA read

- Rebates if biosimilars fail to launch: benefit, high. If enacted, manufacturers that get a two-year delay but then do not have an FDA-licensed and marketed biosimilar would have to pay rebates for the years they delayed pricing. Rebates would be calculated each quarter as 75% of how much the average manufacturer price (AMP) exceeded the benchmark and…
- Two-year biosimilar delay rules: cost, high. This bill would let the Secretary delay listing a biologic as a negotiated drug for two years when a biosimilar is near launch. The Secretary could delay automatically if FDA filings or required studies show a biosimilar is likely to market within two years. A manufacturer could also ask for delay…
- Delay publishing negotiated drug prices: mixed, high. This bill would let the government delay publishing a negotiated maximum fair price and its explanation for an initial year if negotiations are still ongoing. If publication is deferred, that negotiated price would not apply for that initial year. The bill would also tie when a drug counts as a "se…

## Related bills

- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-5269: RESULTS Act
- 119-hr-1340: More Homes on the Market Act
- 119-hr-6130: ASAP Act

## Sources
- [119-hr-10628 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/10628)

## Related
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-5269: RESULTS Act](https://policyrisk.com/legislation/119-hr-5269)
- [119-hr-1340: More Homes on the Market Act](https://policyrisk.com/legislation/119-hr-1340)
- [119-hr-6130: ASAP Act](https://policyrisk.com/legislation/119-hr-6130)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-10628 (as of 2026-10-24).