Bill · H.R. 9661· House(119-HR-9661)
Expedited Access to Biosimilars Act
- Introduced
- 7/14/2026
- Last activity
- 7/14/2026 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Nicholas Langworthy
- Cosponsors
- - 1 - 1
- Introduced
- In Committee
What this bill would do
This bill, known as the "Expedited Access to Biosimilars Act," seeks to amend the Public Health Service Act. It aims to change the default expectation for licensing biological products as biosimilars. Specifically, it limits the requirement for additional clinical studies. Under this act, the Secretary would only require extra studies, such as those assessing pharmacodynamics or efficacy, if they are deemed necessary to demonstrate biosimilarity. The bill also includes provisions for providing written notice regarding these requirements.
Yes· 3 of 4
Does this lower the price of prescription medicines?+5
The bill expedites the licensure of biosimilars, which can increase competition and lower drug prices.
Would households on low incomes be better off under this?+4
Increased competition through expedited biosimilar entry can reduce costs for essential medications.
Does this make health care easier to get in general?+3
Streamlining the biosimilar approval process may lead to more affordable treatment options becoming available.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Streamlined Licensure Process: By amending Section 351(k)(2)(A), the bill limits the Secretary's ability to require additional clinical studies unless they are determined to be necessary to demonstrate biosimilarity. This could potentially expedite the process for biological products to be licensed as biosimilars.
-
Clearer Communication on Study Requirements: Under Section 2(a)(1)(A)(ii), the Secretary must provide written notice if they determine that additional clinical studies are necessary. This notice must be provided by specific deadlines, such as the date a request for a development meeting is granted or within 60 days of an application submission.
Potential Negative Impacts for People
- Reduced Requirement for Clinical Evidence: According to Section 2(a)(1), the Secretary can only require additional studies—including those assessing pharmacodynamics or efficacy—if they determine such studies are necessary to demonstrate biosimilarity. This change means these studies are no longer a default expectation for licensure.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Reduces Prescription Drug Costs+5Improves Healthcare Access+3
- Demographic And Interest Groups
- Good For Low Income Households+4Good For Urban Residents+2
- 7/21/2026
- 1 Cosponsor added.
- 7/14/2026
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
Kim SchrierDemocrat · Washington
Robert WittmanRepublican · Virginia