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119th Congress
Independent · Nonpartisan · Reader-supported
SENATES. 1954· 119th Congress

Bill makes all FDA-approved copycat drugs interchangeable

Biosimilar Red Tape Elimination Act

Sponsor
Mike Lee (R-UT)
Introduced
Jun 4, 2025
Last Action
Jul 27, 2026
Passage
62%
Introduced
Jun 4, 2025
Committee
Jul 27, 2026
3
Floor Vote
4
Both Chambers
5
Enacted
01 — The Text

What.

  • Automatically deems all FDA-licensed biosimilars interchangeable with brand-name originals, eliminating extra safety testing currently required.
  • Takes effect 60 days after passage. Previously licensed biosimilars gain interchangeable status immediately.
  • Preserves exclusive market periods for first biosimilars approved before the law takes effect.
02 — The Stakes

So what?

  • Patients win: Pharmacists can substitute cheaper biosimilar drugs at the counter without prescriber approval, lowering out-of-pocket costs.
  • Generic drugmakers win: Reduced barriers to market entry mean faster competition and lower approval costs.
  • Brand-name manufacturers lose: Broader substitution erodes market protection for expensive original biologics.
03 — The Path

Now what?

  • Passed Senate committee July 27, 2026. Heads to full Senate floor vote; passage momentum appears strong with bipartisan support.
  • Contact your senator to express support or opposition before floor vote.
Legislative History

Actions.

  • Jul 27, 2026Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
  • Jul 27, 2026Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
  • Jul 27, 2026Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
  • Jun 17, 2026Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
  • Jun 4, 2025Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Jun 4, 2025Introduced in Senate