Before you vote › Federal bills
S. 1414: Expedited Access to Biosimilars Act
119th Congress · introduced 2025-04-10 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
federal
Official title
Expedited Access to Biosimilars Act
Plain summary
Expedited 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. 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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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.
Congressional Research Service summary (Reported to Senate), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
Official text
Expedited Access to Biosimilars Act
Source: Congressional Research Service summary (Reported to Senate)
AI explanation – may be wrong, check the official text
No AI explanation yet. It takes up to a minute to write and is then saved for everyone.
Limited to a few requests an hour per person.
The strongest published arguments
Arguments for (supporters)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Arguments against (opponents)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Alternatives
Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.
Officials and money
Sponsor: Sen. Paul, Rand [R-KY] · 2 cosponsors
Money: No cost estimate published yet. No linked contracts or vendors yet.
Words on this page, explained (2)
- 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).
- Statute
- A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Reported to Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119s1414.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/s>
Record fed-us-cong119-s1414 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills