119th Congress · introduced in the Senate · Apr 10, 2025
Expedited Access to Biosimilars Act
Official title from Congress.gov
Latest action (Jul 27, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Reported to Senate (Jul 27, 2026)
Expedited Access to Biosimilars Act
This bill modifies statutory requirements for demonstrating that a proposed biological product (e.g., a drug or vaccine) is biosimilar to a reference (brand-name) product. Specifically, the bill eliminates the need for a clinical efficacy study unless the Food and Drug Administration (FDA) determines such a study is necessary.
Under current law, applicants seeking FDA approval of a proposed biosimilar must submit certain studies and assessments, including a clinical efficacy study demonstrating the safety, purity, and potency of the proposed biosimilar in relevant conditions of use. However, the FDA has discretion not to require studies and assessments it deems unnecessary. (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in some circumstances.)
The bill generally eliminates the requirement that a biosimilar applicant submit a clinical efficacy study but authorizes the FDA to require such a study if necessary. If requiring a clinical efficacy study, the FDA must provide a written determination of necessity to the applicant within a specified period.
Separately, the bill eliminates a requirement that a biosimilar application be reviewed by the same FDA division responsible for review of the reference application.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Actions from Congress.gov, newest first.
Drug safety, medical device, and laboratory regulation · Licensing and registrations · Medical research
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
56 citations; showing the 25 most recently posted.
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$2,560,000
Spent on own lobbying
…Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Sub…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP) · lobbying firm or registrant: AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$3,010,000
Spent on own lobbying
…Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen.…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$7,040,000
Spent on own lobbying
…. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1387: National Biotechnology Initiative Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act fo…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,530,000
Spent on own lobbying
…. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1387: National Biotechnology Initiative Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act fo…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$340,000
Paid to lobbying firm
…36; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HIGHMARK INC · lobbying firm or registrant: HIGHMARK, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$300,000
Spent on own lobbying
PBM Reform, transparency S. 1414, Expedited Access to Biosimilars Act - A bill to provide that clinical studies required for licensure of biological products as biosimilar shall not be require…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CENTER FOR INDIVIDUAL FREEDOM · lobbying firm or registrant: CENTER FOR INDIVIDUAL FREEDOM
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$20,000
Spent on own lobbying
S. 1414 - Expedited Access to Biosimilars Act Correspondence with United States Senate in opposition to the legislation, which would weaken standards of interchangeabi…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
SUN PHARMACEUTICAL INDUSTRIES, INC. · lobbying firm or registrant: SUN PHARMACEUTICAL INDUSTRIES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$140,000
Spent on own lobbying
H.R. 5526 - Biosimilar Red Tape Elimination Act; all provisions. S. 1414 - Expedited Access to Biosimilars Act; all provisions. S. 2658 - Medication Affordability and Patent Integrity Act; all provisions.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE BIOSIMILARS FORUM · lobbying firm or registrant: THORN RUN PARTNERS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$100,000
Paid to lobbying firm
…Pricing Reduction and increasing access to Biosimilars. Inflation Reduction Act implementation. H.R.5526/S.1954 - Biosimilar Red Tape Elimination Act. H.R.9661/S.1414 - Expedited Access to Biosimilars Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE BIOSIMILARS FORUM · lobbying firm or registrant: THORN RUN PARTNERS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$100,000
Paid to lobbying firm
…. Efforts surrounding user fees. S.2256 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026. H.R.9661/S.1414 - Expedited Access to Biosimilars Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$630,000
Spent on own lobbying
…rug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (F…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION OF ACCESSIBLE MEDICINES (FORMERLY KNOWN AS GPHA) · lobbying firm or registrant: FIERCE GOVERNMENT RELATIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…s around country of origin labeling; Supply Chain; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; G…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE CAMPAIGN FOR SUSTAINABLE RX PRICING · lobbying firm or registrant: MEHLMAN CONSULTING, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$90,000
Paid to lobbying firm
…nd Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION OF ACCESSIBLE MEDICINES · lobbying firm or registrant: MEHLMAN CONSULTING, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug Applications Act; Country of origin labeling. H.R. 9661/S. 1414 - Expediated Access to Biosimilars Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Pharmacy
$770,000
Spent on own lobbying
…s Act. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
KAISER FOUNDATION HEALTH PLAN INC · lobbying firm or registrant: KAISER FOUNDATION HEALTH PLAN INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Pharmacy
$500,000
Spent on own lobbying
…, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation th…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL INDUSTRY LABOR MANAGEMENT ASSOCIATION · lobbying firm or registrant: E3 STRATEGIC CONSULTING GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 5, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…Act of 2025; H.R. 5256, 340B ACCESS Act"; S. 3345, "PBM Price Transparency and Accountability Act"; S. 2658, Medication Affordability and Patent Integrity Act; S. 1414, Expedited Access to Biosimilars Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CAMPAIGN FOR SUSTAINABLE DRUG PRICING (CSRXP) · lobbying firm or registrant: WHITMER & WORRALL, LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 22, 2026 · issue area: Pharmacy
$50,000
Paid to lobbying firm
…Act. S. 1095 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 3014 Ensuring Timely Access to Generics Act of 2025 S. 1414 Expedited Access to Biosimilars Act S. 1032/H.R. 1843 Increasing Transparency in Generic Drug Applications Act. S. 2630, Reforming Evergreening and Manipulatio…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Health Issues
$2,360,000
Spent on own lobbying
…BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitutio…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$220,000
Paid to lobbying firm
…46); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP) · lobbying firm or registrant: AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$3,010,000
Spent on own lobbying
…Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen.…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$870,000
Spent on own lobbying
…subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Cons…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
KAISER FOUNDATION HEALTH PLAN INC · lobbying firm or registrant: KAISER FOUNDATION HEALTH PLAN INC.
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$530,000
Spent on own lobbying
…, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation th…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Trade (domestic/foreign)
$580,000
Spent on own lobbying
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufactur…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$580,000
Spent on own lobbying
…rease Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing