Bill · S. 1954· Senate(119-S-1954)
Biosimilar Red Tape Elimination Act
- Introduced
- 6/4/2025
- Last activity
- 7/27/2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
- Sponsored by
- Mike Lee
- Cosponsors
- - 2 - 3
- Introduced
- On Calendar
What this bill would do
The Biosimilar Red Tape Elimination Act aims to change how biological products are determined to be interchangeable with their reference products. It amends the Public Health Service Act to establish that a licensed biological product is deemed interchangeable with its reference product. This change applies to products licensed on or after a transition date, which is 60 days after the act's enactment. The bill also includes provisions to preserve existing interchangeability exclusivity periods. Finally, it requires the Secretary to update various guidance documents regarding biosimilarity and interchangeability.
Yes· 3 of 5
Does this lower the price of prescription medicines?+7
By deeming biosimilars interchangeable upon licensure, the act facilitates easier substitution and competition to lower drug costs.
Would households on low incomes be better off under this?+5
Potential drug cost reductions through easier biosimilar access benefit low-income households.
Would middle-income households be better off under this?+5
Potential drug cost reductions through easier biosimilar access benefit middle-class households.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Automatic Interchangeability Status: A biological product licensed under subsection (k) will be deemed interchangeable with its reference product upon licensure. This change is intended to streamline the process for biological products. (Section 2(a)(4)(A))
-
Streamlined Transition: For products licensed before the transition date, they will be deemed interchangeable on the transition date. This provides a clear timeline for products already in the system. (Section 2(a)(4)(B)(ii))
Potential Negative Impacts for People
- Impact on Existing Exclusivity: The bill includes provisions where a product may not be deemed interchangeable immediately if it relies on the same reference product as another biological product that has an active first interchangeable exclusivity period. In these cases, the deemed interchangeability only occurs once that exclusivity period ends. (Section 2(a)(4)(B)(i) and (ii))
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Low Income Households+5Good For Middle Class Households+5Good For Retirees+5
- Healthcare
- Reduces Prescription Drug Costs+7
- Economy And Finance
- Improves Consumer Protection+5
- 7/27/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
- 6/17/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 6/16/2026
- 1 Cosponsor added.
- 6/24/2025
- 1 Cosponsor added.
- 6/4/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 3 Cosponsors added.
- Introduced in Senate
Maggie HassanDemocrat · New Hampshire
Ben LujánDemocrat · New Mexico
Jon OssoffDemocrat · Georgia
Rand PaulRepublican · Kentucky
Eric SchmittRepublican · Missouri