PlainBillCongress, translated.Legislation. Context. Public interest.Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
Congressional Research Service
Version 00 · Introduced in Senate · Jun 4, 2025
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.
Showing the opening paragraphs of the official summary.
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 (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching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.
People & committees
Sen. Lee, Mike [R-UT] · R–UT
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 3, 2026. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze S.1954 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine S.1954 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine S.1954 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine S.1954 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.