119th Congress Health
S. 1954: Biosimilar Red Tape Elimination Act
Reported
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This 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 (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching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.)
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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.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Margaret Hassan D-NHOriginal
- Ben Luján D-NMOriginal
- Rand Paul R-KYOriginal
- Eric Schmitt R-MO
- Jon Ossoff D-GA
Who scored on this bill
- 1Mike Lee SponsorDrew cross-party cosponsors, introduced, reported3 events+26
See all scorers and every scoring event
Introductions and cosponsorships count toward weekly caps and show no points.
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History
- Introduced in the Senate by Mike Lee.
Show the full action history (5 actions)
- 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.
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Introduced in Senate
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.