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S. 1954119th CongressHealth
Biosimilar Red Tape Elimination Act
Sponsored by Sen. Mike Lee (R-UT) · 5 active : 2 Republicans, 3 Democrats
Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
Where it standsBefore the Senate8 senators score as swing votes
Hasn’t passed either chamber
- Senate: next
- House: not yet
- President: not yet
Summary
, via Congress.govBiosimilar Red Tape Elimination Act
This bill deems all biosimilars licensed by the Food and Drug Administration (FDA) interchangeable with their reference products.
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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 (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching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.
Committees and subjects
Committees
- Senate Committee on Health, Education, Labor, and Pensions · SenateReported by · Markup by · Referred to
Subjects
- Drug safety, medical device, and laboratory regulation
- Government information and archives
- Licensing and registrations
- Prescription drugs
How the Senate breaks down
- 8Swing 70–100
- 59Middle 30–70
- 33Entrenched 0–30
Members fall into . All 100 senators have enough data to score.
Key players in the Senate
Ranked by swing score, 0–100 · swing-v2, directional: only movement toward the other party counts, so members who sit further from the center than their party no longer score as swing votes.
Bars show each input from 0 to 100: ideology gap, scorecard gap, . is the seat’s partisan lean, and shows how much of the input data a score has.
Similar past votes, Senate
Earlier behind swing-v3’s inputLoading similar votes
Cosponsors
5 activeShow all 5 cosponsors
- Ben Ray Luján (D-NM)
- Margaret Wood Hassan (D-NH)
- Rand Paul (R-KY)
- Eric Schmitt (R-MO)
- Jon Ossoff (D-GA)
How the swing score works
Ideology gapHow far a member’s DW-NOMINATE voting score sits from their party’s median in the same chamber.
Scorecard gapHow far their Heritage Action and LCV ratings stray from their party’s average, using the groups’ votes on similar bills where available.
Cross-pressureHow strongly their district or state leans toward the other party, from our own computed partisan lean.
Similar votesHow often they voted against their own party on earlier roll calls about this bill or similar ones.
Committee bonusMembers of the committees handling the bill decide whether it moves, so they get a boost.
Cosponsor checkThe sponsor and active cosponsors have already committed, so they drop toward entrenched.
