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S. 2305 118th Congress Senate

Biosimilar Red Tape Elimination Act

Official title: A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product.

Introduced: July 13, 2023 Introduced by: Mike Lee Republican · Utah See on congress.gov
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This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 13, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 13, 2023
Introduced in Senate
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 Latest action July 13, 2023

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Plain-English summary Congressional Research Service

Biosimilar Red Tape Elimination Act

This bill removes certain requirements for biosimilars to be designated as interchangeable. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.)

Specifically, the bill establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar (i.e., a product that is the first interchangeable biosimilar to be approved with respect to the reference product).

The Food and Drug Administration (FDA) may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.

 

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 14

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

See all 14 filings →
 Cosponsors 2
All 2 Democratic 1 Republican 1
R
Paul, Rand
Kentucky · Sep 11, 2023
 D
Luján, Ben Ray
New Mexico · Jul 13, 2023
Cite this page click to expand
APA
U.S. Congress. (2026). S. 2305: Biosimilar Red Tape Elimination Act. 118th Congress. Open America. https://openamerica.io/bill/118-S-2305/
MLA
"S. 2305: Biosimilar Red Tape Elimination Act." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-2305/.
Bluebook (legal)
S. 2305, 118th Cong. (2026), https://openamerica.io/bill/118-S-2305/.
Markdown link
[S. 2305: Biosimilar Red Tape Elimination Act](https://openamerica.io/bill/118-S-2305/)
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