R Street Joins 38 other Organizations in Support of the Biosimilar Red Tape Elimination Act

July 7, 2025

RE: Biosimilar Red Tape Elimination Act (S. 1954)

Dear Chairman Cassidy, Chairman Guthrie, Ranking Member Pallone, Ranking Member Sanders:

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.

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. Further, biosimilar competition has expanded patient access by nearly 500 million days of therapy.

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no scientific difference between biosimilars and interchangeable biologics and has recommended that Congress remove the outdated distinction.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.

With its recent introduction, we look forward to continuing to work with you, as leaders of the committees of jurisdiction, to achieve its enactment.

For a full list of signatories, see the original letter below: