Bill would drop extra FDA testing step for interchangeable biosimilar drugs
Placed on the calendarS. 1954Latest action
Sponsor: Mike Lee · Senator · UT
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Official title: Biosimilar Red Tape Elimination Act
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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S 1954 would automatically make approved biosimilars interchangeable, ending the separate testing step pharmacists currently need for substitution.
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What does this do?
This bill removes the separate "interchangeable" category for biosimilar drugs, so any biosimilar approved by the FDA would automatically be treated as interchangeable without extra testing. It sets a 60-day transition period and requires the FDA to update guidance documents within 18 months, while protecting some companies' existing exclusive rights tied to being first "interchangeable."
Who does it affect?
Drug manufacturers (especially biosimilar makers), the FDA, pharmacists, insurance companies, and patients using biologic medications.
Why does it matter?
Removing the separate interchangeable testing requirement changes how pharmacists determine which biosimilars can be automatically substituted for brand-name biologics without a doctor's new prescription.
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Read the official bill on Congress.govMake the call
Where does it stand?
- IntroducedJun 4, 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. 521.