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S. 1954: Biosimilar Red Tape Elimination Act
119th Congress · introduced 2025-06-04 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
federal
Official title
Biosimilar Red Tape Elimination Act
Plain summary
Biosimilar Red Tape Elimination Act 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 (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching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.) 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.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
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Official text
Biosimilar Red Tape Elimination Act
Source: Congressional Research Service summary (Introduced in Senate)
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Officials and money
Sponsor: Sen. Lee, Mike [R-UT] · 5 cosponsors
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Words on this page, explained (1)
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119s1954.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/s>
Record fed-us-cong119-s1954 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills