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S. 1954119th Congress
Official title: Biosimilar Red Tape Elimination Act
Introduced:
Read the official bill on Congress.govS. 1954
The plain-language version leads. The official text is always the reference.
S 1954 would automatically make approved biosimilars interchangeable, ending the separate testing step pharmacists currently need for substitution.
35-second read · 4 questions answered below
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."
Drug manufacturers (especially biosimilar makers), the FDA, pharmacists, insurance companies, and patients using biologic medications.
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.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: it's on the Senate floor calendar. 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.