S 1954 119th Congress
Biosimilar Red Tape Elimination Act
A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product.
Official Title as Introduced Congress.gov
Open official Congress.gov recordSource-linked procedural record
Bill journey
This is a chronology, not a progress score. Politically.com does not classify stages or infer what comes next. Records sharing a date are grouped because not every source field supplies a time.
Congress.gov Recently refreshed
U.S. Senate XML Recently refreshed
-
Introduction Congress.gov
Introduced
Introduced in the Senate.
Open bill recordOfficial action Congress.gov
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Open bill recordOfficial action Congress.gov
Introduced in Senate
Open bill recordText version Congress.gov
Introduced in Senate
A dated text-version record is available.
Open text record -
Official action Congress.gov
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Open bill record -
Official action Congress.gov
Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
Open bill recordOfficial action Congress.gov
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Open bill recordOfficial action Congress.gov
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Open bill recordText version Congress.gov
Reported to Senate
A dated text-version record is available.
Open text record
View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 521. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS summary
Biosimilar Red Tape Elimination ActThis bill deems all biosimilars licensed by the Food and Drug Administration (FDA) interchangeable with their reference products.A biosimilar is a biological product (e.g., a drug or vaccine) that is very similar to a brand-name biological product (i.e., the reference product). Under current law, a biosimilar that meets additional requirements may be deemed interchangeable with the reference product; this designation allows pharmacists to substitute the interchangeable biosimilar when filling a prescription for the reference product, depending on state law. Further, the first biosimilar deemed interchangeable with a given reference product is awarded a period of marketing exclusivity.The bill eliminates additional requirements for demonstrating interchangeability so that all licensed biosimilars are deemed interchangeable with their reference products. (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching between use of the biosimilar and reference product. It has not been finalized.)This change takes effect 60 days after the bill is enacted, and previously licensed biosimilars must be deemed interchangeable with their reference products on that date. However, the bill preserves the exclusivity period for first interchangeable biosimilars licensed before the bill’s enactment. For example, if a new biosimilar licensed after the bill takes effect relies on the same reference product as an existing biosimilar that is subject to an unexpired exclusivity period, the new biosimilar is not deemed interchangeable with the reference product until the exclusivity period has ended.
Official documents
Text versions
- Reported to SenateJul 27, 2026
- Introduced in SenateJun 4, 2025