# 119-s-5571: Biosimilars Access and Affordability Act

119-s-5571, Biosimilars Access and Affordability Act, is a 119th Congress bill sponsored by Sen. Blackburn, Marsha [R-TN] (R-TN); status introduced; PRIA reads it as touching household money (as of 2026-10-15).

- Canonical: https://policyrisk.com/legislation/119-s-5571
- As of: 2026-10-15
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-5571
- Congress: 119
- Title: Biosimilars Access and Affordability Act
- Status: introduced
- Introduced: 2026-09-28
- Sponsor: Sen. Blackburn, Marsha [R-TN] (R-TN)
- Cosponsors: 3
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-10-15

## Summary

**Two-pathway, two-year delay** that changes when biosimilars enter Medicare price negotiations. It also adds disclosure duties, a "high likelihood" test, and new rebate and price-adjustment rules. - Manufacturers must disclose licensure status, study progress, and expected launch dates and confirm those facts in writing under penalty of perjury. False confirmations trigger enforcement and manufacturers can owe rebates if they do not license and market within the delay. - The bill ties a drug's negotiation start to its selected drug publication date and creates automatic and request-based delays that can push inclusion by up to two years. The maximum fair price does not apply during the initial price applicability year and the changes apply to initial price applicability years beginning 2026. - When delays apply, the law imposes price-adjustment formulas for each missed quarter that reclaim part of excess costs: 75 percent of average manufacturer price excess and 80 percent of the payment amount excess. It also creates a formal "high likelihood" standard for delay-on-request decisions and says pending patent litigation will not block a delay.

## Cosponsors (3)

- Sen. Schiff, Adam B. [D-CA] (D-CA), 2026-09-28T00:00:00.000Z
- Sen. Lankford, James [R-OK] (R-OK), 2026-09-28T00:00:00.000Z
- Sen. Budd, Ted [R-NC] (R-NC), 2026-09-28T00:00:00.000Z

## Provisions PRIA read

- Manufacturer rebates for biosimilar delays: mixed, medium. This bill would require drug makers to pay quarterly rebates if a biosimilar is not licensed and marketed within two years after the selected-drug publication date. For Part D the rebate would be 75% of the amount the product's average manufacturer price (AMP) exceeds the applicable maximum fair pr…
- Delay Medicare biosimilar price talks: mixed, low. This bill would let the Secretary delay treating some biological products as selected drugs for Medicare negotiation for up to two years when a biosimilar is expected within that window. There would be an automatic two-year pathway and a delay-on-request pathway that requires a high-likelihood find…

## Related bills

- 119-s-4744: Take Care of America’s Veterans Act
- 119-s-3597: National Quantum Initiative Reauthorization Act of 2026
- 119-s-5025: Lindsey O. Graham Sanctioning Russia Act of 2026
- 119-s-1241: Sanctioning Russia Act of 2025
- 119-s-199: A bill to amend the Internal Revenue Code of 1986 to provide special rules for the taxation of certain residents of Taiwan with income from sources within the…
- 119-s-4429: Connected Vehicle Security Act of 2026

## Sources
- [119-s-5571 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/5571)

## Related
- [119-s-4744: Take Care of America’s Veterans Act](https://policyrisk.com/legislation/119-s-4744)
- [119-s-3597: National Quantum Initiative Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3597)
- [119-s-5025: Lindsey O. Graham Sanctioning Russia Act of 2026](https://policyrisk.com/legislation/119-s-5025)
- [119-s-1241: Sanctioning Russia Act of 2025](https://policyrisk.com/legislation/119-s-1241)
- [119-s-199: A bill to amend the Internal Revenue Code of 1986 to provide special rules for…](https://policyrisk.com/legislation/119-s-199)
- [119-s-4429: Connected Vehicle Security Act of 2026](https://policyrisk.com/legislation/119-s-4429)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-5571 (as of 2026-10-15).