Bill would ease FDA testing rules for cheaper biosimilar drugs
Placed on the calendarS. 1414Latest action
Sponsor: Rand Paul · Senator · KY
AIDecoded by AI · checked against the recordRead the official text
Official title: Expedited Access to Biosimilars Act
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
The plain-language version comes first. The official text is always the reference.
S 1414 would let biosimilar makers skip certain clinical studies unless the FDA specifically requires them in advance.
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What does this do?
The bill would end the automatic requirement for immunogenicity, pharmacodynamics, and comparative efficacy studies for biosimilar drug approval. Companies would instead only need to show safety and expected results in one approved use through simpler pharmacokinetic testing. The FDA could still require the extra studies case by case, but only with early written notice explaining why.
Who does it affect?
This mainly affects pharmaceutical companies developing biosimilar drugs, which are cheaper alternatives to complex biologic medicines used for conditions like arthritis, cancer, or diabetes. Patients and doctors could also be affected through changes in access to and confidence in these drugs.
Why does it matter?
Fewer required studies could shorten approval timelines and lower development costs for biosimilar makers, while raising questions for some about whether reduced testing affects confidence in drug safety or effectiveness. The change would apply only to applications submitted after the law takes effect.
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Read the official bill on Congress.govMake the call
Where does it stand?
- IntroducedApr 10, 2025
- Senate committee
- Senate voteYou are here · Jul 27, 2026
- House
- The president's desk
Right now: it was placed on the , and the official record shows no floor action on it since. If the House changes it, it goes back to the Senate before reaching the president.
Latest action: — Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.