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S. 1414119th CongressHealth
Expedited Access to Biosimilars Act
Sponsored by Sen. Rand Paul (R-KY) · 2 active : 1 Republican, 1 Democrat
Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
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.govExpedited Access to Biosimilars Act
This bill modifies statutory requirements for demonstrating that a proposed biological product (e.g., a drug or vaccine) is biosimilar to a reference (brand-name) product. Specifically, the bill eliminates the need for a clinical efficacy study unless the Food and Drug Administration (FDA) determines such a study is necessary.
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Under current law, applicants seeking FDA approval of a proposed biosimilar must submit certain studies and assessments, including a clinical efficacy study demonstrating the safety, purity, and potency of the proposed biosimilar in relevant conditions of use. However, the FDA has discretion not to require studies and assessments it deems unnecessary. (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in some circumstances.)
The bill generally eliminates the requirement that a biosimilar applicant submit a clinical efficacy study but authorizes the FDA to require such a study if necessary. If requiring a clinical efficacy study, the FDA must provide a written determination of necessity to the applicant within a specified period.
Separately, the bill eliminates a requirement that a biosimilar application be reviewed by the same FDA division responsible for review of the reference application.
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
- Licensing and registrations
- Medical research
How the Senate breaks down
- 8Swing 70–100
- 61Middle 30–70
- 31Entrenched 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
2 activeShow all 2 cosponsors
- Mike Lee (R-UT)
- Margaret Wood Hassan (D-NH)
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.
