A Republican bill with 4 Democratic cosponsors · See all 10 cosponsors
Last activity — Referred to the House Committee on Energy and Commerce.
In committee
Introduced and handed to a committee in the chamber it started in.
The committee holds it, and most bills are never heard from again. A hearing or a committee vote would be news; silence is the usual outcome, and it kills the bill without anyone voting against it.
Its path through Congress
- Introduced
- In Committee
What this bill would do
The Biosimilar Red Tape Elimination Act aims to change how biological products are determined to be interchangeable with their reference products. Under this bill, a biological product licensed under section 351(k) would be deemed interchangeable with the reference product. This change includes specific timing rules for products licensed before or after a designated transition date. The bill also maintains unexpired exclusivity periods for certain biological products. Additionally, the Secretary is required to update various guidance documents related to biosimilarity and interchangeability.
Yes· 3 of 7
- Scored +5
Does this lower the price of prescription medicines?
Deeming biological products interchangeable with their reference products aims to facilitate the market entry of more affordable biosimilars.
- Scored +4
Would households on low incomes be better off under this?
Lower prescription drug costs resulting from increased biosimilar competition may disproportionately benefit low-income households.
- Scored +4
Would middle-income households be better off under this?
Potential savings on prescription drugs could alleviate financial burdens on middle-income families.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Streamlined Interchangeability Determination: A biological product licensed under this subsection shall be deemed to be interchangeable with the reference product, subject to certain timing rules (Section 2(a)(4)).
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Updated Regulatory Guidance: The Secretary is required to update or issue guidance regarding the review and approval of biosimiliar biological products within 18 months to reflect the new amendments (Section 2(c)).
Potential Negative Impacts for People
- Delayed Interchangeability for Certain Products: A biological product may not be deemed interchangeable until a specific exclusivity period ends if it relies on the same reference product as another biological product that had licensure in effect before the Act's enactment (Section 2(a)(4)(B)(i) and (ii)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Tap or hover a score for the reason it gave.
- Demographic And Interest Groups
- Would business owners be better off under this? — Streamlining the interchangeability process creates a more efficient regulatory environment for pharmaceutical manufacturers. Would households on low incomes be better off under this? — Lower prescription drug costs resulting from increased biosimilar competition may disproportionately benefit low-income households. Would middle-income households be better off under this? — Potential savings on prescription drugs could alleviate financial burdens on middle-income families.
- Healthcare
- Does this lower the price of prescription medicines? — Deeming biological products interchangeable with their reference products aims to facilitate the market entry of more affordable biosimilars. Does this make health care easier to get in general? — Increased competition from biosimilars through easier interchangeability determinations may lower costs and improve access to treatments.
- Economy And Finance
- Does this make it easier to run a small business? — The bill streamlines the regulatory pathway for biosimilar products, which may reduce entry barriers for manufacturers.
- Governance And Ideology
- Does this make what the government does easier for the public to see? — The bill requires the Secretary to update and issue updated guidance regarding biosimilar review and approval processes.
- 7/21/2026
- 1 Cosponsor added.
- 7/15/2026
- 1 Cosponsor added.
- 6/4/2026
- 1 Cosponsor added.
- 5/21/2026
- 1 Cosponsor added.
- 3/9/2026
- 1 Cosponsor added.
- 2/4/2026
- 1 Cosponsor added.
- 12/9/2025
- 1 Cosponsor added.
- 11/10/2025
- 1 Cosponsor added.
- 10/17/2025
- 1 Cosponsor added.
- 9/19/2025
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
Jake AuchinclossDemocrat · Massachusetts
Dan CrenshawRepublican · Texas
Randy FineRepublican · Florida
Craig GoldmanRepublican · Texas
Greg LandsmanDemocrat · Ohio
Blake MooreRepublican · Utah
Burgess OwensRepublican · Utah
Eric SorensenDemocrat · Illinois
Gabe VasquezDemocrat · New Mexico
Robert WittmanRepublican · Virginia