119th Congress · introduced in the Senate · Jun 4, 2025
Biosimilar Red Tape Elimination Act
Official title from Congress.gov
Latest action (Jul 27, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in Senate (Jun 4, 2025)
Biosimilar Red Tape Elimination Act
This bill deems all biosimilars licensed by the Food and Drug Administration (FDA) interchangeable with their reference products.
A biosimilar is a biological product (e.g., a drug or vaccine) that is very similar to a brand-name biological product (i.e., the reference product). Under current law, a biosimilar that meets additional requirements may be deemed interchangeable with the reference product; this designation allows pharmacists to substitute the interchangeable biosimilar when filling a prescription for the reference product, depending on state law. Further, the first biosimilar deemed interchangeable with a given reference product is awarded a period of marketing exclusivity.
The bill eliminates additional requirements for demonstrating interchangeability so that all licensed biosimilars are deemed interchangeable with their reference products. (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching between use of the biosimilar and reference product. It has not been finalized.)
This change takes effect 60 days after the bill is enacted, and previously licensed biosimilars must be deemed interchangeable with their reference products on that date. However, the bill preserves the exclusivity period for first interchangeable biosimilars licensed before the bill’s enactment. For example, if a new biosimilar licensed after the bill takes effect relies on the same reference product as an existing biosimilar that is subject to an unexpired exclusivity period, the new biosimilar is not deemed interchangeable with the reference product until the exclusivity period has ended.
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. 521.
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.
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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.
140 citations; showing the 25 most recently posted.
BCBSM INC · lobbying firm or registrant: BCBSM, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Pharmacy
$30,000
Spent on own lobbying
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference pr…
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
AMGEN · lobbying firm or registrant: THE NICKLES GROUP, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…e. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and Patent Integrity 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
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
…search 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 Substitution Cell & Gene Therapy ---H.R.1672: Main…
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 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Medicare/Medicaid
$2,560,000
Spent on own lobbying
…els Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovati…
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
BLUE CROSS AND BLUE SHIELD OF KANSAS INC · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD OF KANSAS, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$10,000
Spent on own lobbying
Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference pr…
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
…Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill…
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 PERMANENTE FEDERATION, LLC · lobbying firm or registrant: THE PERMANENTE FEDERATION, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medical/Disease Research/Clinical Labs
$110,000
Spent on own lobbying
S.1954 - Biosimilar Red Tape Elimination 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
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
…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 for FY 2026) S. 2658: Medication Affordability…
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
…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 for FY 2026) S. 2658: Medication Affordability…
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
…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 draft; Alex and Jacis Law discussion draft; Untitled dis…
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
AMGEN, INC. · lobbying firm or registrant: AVENUE SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…d reimbursement for prescription drugs; Issues related to H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act; Issues related to H.R. 5526/S. 1954, Biosimilar Red Tape Elimination Act; Issues related to Senate Finance Dear Colleague process; H.R. 10628/S. 5571, Biosimilars Access and Affordability 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
JOHNSON & JOHNSON SERVICES INC · lobbying firm or registrant: JOHNSON & JOHNSON SERVICES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$2,220,000
Spent on own lobbying
…venue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act, regarding all provisions - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for Children Act of 2025, regarding…
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
BLUE CROSS AND BLUE SHIELD OF FLORIDA INC · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD OF FLORIDA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$100,000
Spent on own lobbying
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference pr…
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
BLUE CROSS AND BLUE SHIELD ASSOCIATION · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$1,240,000
Spent on own lobbying
Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference pr…
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
…FDA regulations of biosimilars. Issues related to Drug 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
GUIDEWELL MUTUAL HOLDING CORPORATION · lobbying firm or registrant: GUIDEWELL MUTUAL HOLDING CORPORATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
Amount not reported
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference pr…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
AMERICAN COLLEGE OF RHEUMATOLOGY · lobbying firm or registrant: AMERICAN COLLEGE OF RHEUMATOLOGY
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$50,000
Spent on own lobbying
…e plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residenc…
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
AMERICAN COLLEGE OF RHEUMATOLOGY · lobbying firm or registrant: AMERICAN COLLEGE OF RHEUMATOLOGY
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Budget/Appropriations
$50,000
Spent on own lobbying
…e plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residenc…
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
AMERICAN COLLEGE OF RHEUMATOLOGY · lobbying firm or registrant: AMERICAN COLLEGE OF RHEUMATOLOGY
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Spent on own lobbying
…e plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residenc…
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
…H.R. 10369: Net Effective Cost Transparency and Prescription Drug 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.…
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
VIZIENT INC · lobbying firm or registrant: VIZIENT, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$300,000
Spent on own lobbying
…tinuing funding for Community Health Centers beyond current expiration. Continued monitoring and encouraged passage of the Biosimilar Red Tape Elimination Act (S.1954). Continued monitoring and encouraged passage of the Improving Seniors' Timely Access to Care Act (H.R. 3514/S.1816). Continued monitoring and encouraged passa…
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
TAKEDA PHARMACEUTICALS AMERICA INC · lobbying firm or registrant: TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,450,000
Spent on own lobbying
…ated provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policie…
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
…ain; 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; General Business Issues.
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
Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY)…
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
Issues related to pharmaceutical manufacturing supply chain. S. 1040 - Drug Competition Enhancement Act; H.R. 5526/S. 1954 -Biosimilar Red tape Elimination Act; H.R. 3269 - ETHIC Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug…
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