A Republican bill with 1 Democratic cosponsor · See all 2 cosponsors
Last activity — Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Cleared committee, waiting for its first floor vote
A committee approved it and it is on the calendar of the chamber it started in.
This is further than most bills get, and still no promise of a vote: the calendar is a queue, and the majority leadership decides what is called. A bill can sit here until the Congress ends.
Its path through Congress
- Introduced
- On Calendar
What this bill would do
The "Expedited Access to Biosimilars Act" changes the rules for getting biological products licensed as biosimilars. It limits when the Secretary can require clinical studies that assess pharmacodynamics or efficacy. If these studies are required, the Secretary must provide a written determination and justification to the sponsor. The bill also streamlines biosimilar reviews and applies to applications submitted on or after the date it becomes law.
Yes· 3 of 32
- Scored +8
Does this lower the price of prescription medicines?
Expediting biosimilar access increases market competition, which typically drives down the cost of biological drugs.
- Scored +6
Would households on low incomes be better off under this?
Reducing the cost of high-priced biological products significantly benefits low-income patients.
- Scored +6
Does this make health care easier to get in general?
Faster approval of biosimilars increases the availability of critical biological therapies for patients.
The opposite
- Scored -2
Does this give people more protection from unfair business practices?
Reducing the requirement for certain clinical efficacy studies could potentially lower the data available for safety/efficacy verification.
Who it would affect, and how
Potential Positive Impacts for People
-
Faster Access to Biosimilars: By limiting the requirement for certain clinical studies on pharmacodynamics or efficacy (Section 2(a)(2)(II)(aa)), the process for licensing biosimilar products may be expedited.
-
Greater Transparency and Accountability: The Secretary must now provide a written determination or notice explaining why certain studies are necessary (Section 2(a)(2)(II)(bb)), which holds officials accountable for their requirements.
-
Predictability for Product Sponsors: The bill prevents the Secretary from amending a determination to require new studies unless there is a written agreement or a detailed scientific justification (Section 2(a)(2)(II)(cc)).
Potential Negative Impacts for People
- Reduced Clinical Data: The bill changes the requirements so that assessments of pharmacodynamics or efficacy are only required if the Secretary determines they are necessary (Section 2(a)(2)(II)(aa)), which could mean fewer clinical studies are conducted for some biosimilars.
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 households on low incomes be better off under this? — Reducing the cost of high-priced biological products significantly benefits low-income patients. Would middle-income households be better off under this? — Lower healthcare costs reduce the overall financial burden on middle-class families. Would business owners be better off under this? — Biopharmaceutical company owners benefit from streamlined and more predictable approval processes. Would people with disabilities be better off under this? — Many people with chronic disabilities rely on biological products; lower costs improve their quality of life. Would retired people be better off under this? — Retirees on fixed incomes benefit significantly from reduced prescription drug costs. Would high-income households be better off under this? — General improvement in medication availability and cost. Would people over 65 be better off under this? — Seniors often rely heavily on biological medications and will benefit from increased competition and lower prices. Would veterans be better off under this, taking everything together? — Veterans may see improved access to affordable biosimilars through VA channels. Would Black Americans be better off under this? — Increased drug affordability benefits all racial groups, including marginalized ones. Would Asian Americans be better off under this? — Increased drug affordability benefits all racial groups, including marginalized ones. Would children be better off under this? — Children needing biological therapies may benefit from lower costs and wider availability. Would Hispanic Americans be better off under this? — Increased drug affordability benefits all racial groups, including marginalized ones. Would immigrants be better off under this? — Lower drug costs improve healthcare access for immigrant populations. Would LGBTQ people be better off under this? — Improved affordability of healthcare medications benefits the community. Would men be better off under this? — Men utilizing biological therapies benefit from lower costs. Would people in middle age be better off under this? — Middle-aged adults may benefit from increased access to lower-cost biosimilars. Would Native Americans be better off under this? — Increased drug affordability benefits all racial groups, including marginalized ones. Would white Americans be better off under this? — Increased drug affordability benefits all racial groups. Would women be better off under this? — Women utilizing biological therapies (e.g., for autoimmune diseases) benefit from lower costs. Would people in their twenties and thirties be better off under this? — Young adults requiring biologicals may benefit from increased affordability.
- Healthcare
- Does this lower the price of prescription medicines? — Expediting biosimilar access increases market competition, which typically drives down the cost of biological drugs. Does this make health care easier to get in general? — Faster approval of biosimilars increases the availability of critical biological therapies for patients. Does this lower what a hospital stay costs? — Lower costs for biological treatments administered in hospitals can reduce overall operational costs. Does this help veterans get medical care? — Veterans may benefit from lower-cost and more available biosimilar medications. Does this lower what people pay for private health insurance? — Lower drug costs due to more biosimilar options may lead to reduced insurance premiums over time.
- Governance And Ideology
- Does this make what the government does easier for the public to see? — The bill requires the Secretary to provide written determinations and justifications for clinical study requirements. Does this protect the right to fair treatment by the courts? — Provides sponsors with more predictable and documented regulatory requirements from the FDA.
- Economy And Finance
- Is this likely to grow the economy? — Reducing regulatory hurdles for biological products fosters innovation and market competition. Is this likely to create jobs? — Streamlining biosimilar approvals may encourage pharmaceutical investment and industry growth. Is this likely to slow the rise in prices? — Increased competition from biosimilars can lower drug prices, slightly mitigating healthcare-driven inflation. Does this give people more protection from unfair business practices? — Reducing the requirement for certain clinical efficacy studies could potentially lower the data available for safety/efficacy verification.
- National Security And Foreign Policy
- Does this increase the pay, pensions or support veterans receive? — Veterans may have better access to more affordable biosimilar biologicals.
- Social Issues And Justice
- Is this likely to lift people out of poverty? — Lower medication costs reduce the financial burden on low-income patients.
- 7/27/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
- 7/22/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 7/20/2026
- 1 Cosponsor added.
- 6/3/2025
- 1 Cosponsor added.
- 4/10/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate
Maggie HassanDemocrat · New Hampshire
Mike LeeRepublican · Utah