39 Groups support the Biosimilar Red Tape Elimination Act
WASHINGTON (July 8, 2025) — The Biosimilars Council and the Association for Accessible Medicines today sent a letter to U.S. Senate and House health committee leaders in support of S. 1954, the Biosimilar Red Tape Elimination Act. The letter was signed by over 39 leading advocacy groups representing health care, patients, consumers, employers, taxpayers, and policy think tanks.
“Interchangeability is a designation that doesn’t exist anywhere else in the world and there is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” said John Murphy III, President and CEO of AAM. “The number of groups who’ve joined us in support of this bill shows how impactful cleaning up this confusion will be for patients.”
The letter reads: “On behalf of patients, providers, taxpayers, and consumers, thank you for your leadership in re-introducing the Biosimilar Red Tape Elimination Act (S. 1954). The Biosimilar Red Tape Elimination Act would remove the distinction between biosimilars and interchangeable biosimilars. In doing so, the legislation would increase patient access to essential biosimilar medications and reduce healthcare costs.”
Giuseppe Randazzo, Senior Vice President, Sciences and Regulatory Affairs, Biosimilars Council & Association for Accessible Medicines said, “The Biosimilars Council thanks the bill sponsors and all the groups who have joined us in supporting this legislation that will increase access and reduce red tape for biosimilars. The FDA has made clear that this arbitrary designation creates confusion, and that scientifically, biosimilars and interchangeables are not distinguishable.”
Since biosimilars first entered the market in 2015, they have generated savings of more than $36 billion and have been used in more than 2.6 billion days of patient therapy with no clinically meaningful differences in patient safety or outcomes. Biosimilar competition has expanded patient access by nearly 500 million days of therapy.
Dr. Yim Sarah Yim, M.D., director of the FDA’s Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, pointed at our GRx+Biosims conference, “Put simply, an interchangeable designation only impacts ease of access, not the quality of the drug.”
The letter continues, “Unfortunately, the statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines. The Food and Drug Administration (FDA) has consistently affirmed that there is no scientific difference between biosimilars and interchangeable biologics and has recommended that Congress remove the outdated distinction. The Biosimilar Red Tape Elimination Act (S. 1954) is consistent with FDA’s science-based recommendation and represents an important step toward building confidence and streamlining patient access to biosimilar medicines.”
The letter was sent to Senators Cassidy, M.D. (R-LA) and Sanders (I-VT), chair and ranking member of the Senate Health Committee, and Representatives Guthrie (R-AL) and Pallone (D-NJ), chair and ranking member of the U.S. House Committee on Energy & Commerce.
The letter is signed by: Academy of Managed Care Pharmacy; AffirmedRx; AHIP; Allergy & Asthma Network; Alliance of Community Health Plans; Americans for Prosperity; American Society for Health-System Pharmacists; Blue Cross Blue Shield Association; Blue Shield of CA; Campaign for Sustainable Rx Pricing; CancerCare; Cancer Support Community; Consumer Action; CVS Health; Economic Alliance for Michigan; Heartland Impact; Heritage Action for America; Kaiser Permanente; LIBRE Initiative; Lymphoma Research Foundation; National Alliance of Healthcare Purchaser Coalitions; National Association of Chain Drug Stores; National Association of Hispanic Nurses; National Consumers League; National Hispanic Health Foundation; National Patient Advocate Foundation; Prime Therapeutics; Public Citizen; Public Sector HealthCare Roundtable; Spina Bifida Association; Taxpayers Protection Alliance; The Bipartisan Policy Center; The ERISA Industry Committee; The Heartland Institute; The Mended Hearts, Inc.; The R Street Institute; Transparency-Rx; U.S. PIRG; Washington Health Alliance.
AAM letter to Congressional Committees in Support of the Biosimilar Red Tape Elimination Act
AAM Applauds Senate Introduction of the Biosimilar Red Tape Elimination Act
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About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 13.1 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available at biosimilarscouncil.org.
