AI-assisted analysis based on the official CRS summary. Source version: Jul 31, 2026. Analysis updated: Sep 15, 2026.
01 — The Text
What.
- Current law allows biosimilars to be deemed interchangeable with reference products only if they meet additional FDA requirements; this bill eliminates those additional requirements
- Under the bill, all biosimilars licensed by the FDA would be automatically deemed interchangeable with their reference products
- The change would take effect 60 days after enactment, and biosimilars licensed before enactment would be deemed interchangeable on that date
- The bill preserves the existing marketing exclusivity period granted to the first biosimilar deemed interchangeable for a given reference product
- Biosimilars licensed after the bill takes effect would not be deemed interchangeable during any unexpired exclusivity period held by a previously licensed biosimilar for the same reference product
02 — The Stakes
So what?
- Pharmacists would gain authority to substitute any FDA-licensed biosimilar when filling prescriptions for reference products, subject to state law
- The documented effect is removal of interchangeability demonstration requirements; effects on drug prices, adoption rates, or patient access are not established in the official summary
- First-mover biosimilar exclusivity periods would continue to block later biosimilars from automatic interchangeability status until exclusivity expires
03 — The Path
Now what?
- Senate Committee on Health, Education, Labor, and Pensions reported the bill with an amendment on July 27, 2026
- The bill was placed on Senate Legislative Calendar (Calendar No. 521) on July 27, 2026
- No recorded floor action or scheduled vote date
Legislative History
Actions.
- Jul 27, 2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
- Jul 27, 2026 — Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Jul 27, 2026 — Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Jun 17, 2026 — Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Jun 4, 2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Jun 4, 2025 — Introduced in Senate