Coalition Letter in Support of the Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526)

January 21, 2026

RE: Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526)

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

Now that there has been bicameral, bipartisan introduction of the Biosimilar Red Tape Elimination Act by Representatives August Pfluger (R-TX) and Greg Landsman (D-OH) (H.R. 5526) as well as Senators Mike Lee (R-UT), Ben Ray Lujan (D-NM), Rand Paul (R-KY), and Maggie Hassan (D-NH) (S. 1954), on behalf of patients, providers, taxpayers, and consumers, we urge you to advance this crucial legislation. 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 $56 billion and have been used in more than 3.3 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. Most recently, FDA Commissioner Marty Makary, M.D., M.P.H., announced the Agency’s intent to finalize guidance eliminating the requirement for switching studies and reiterated the FDA’s recommendation that Congress remove this unnecessary distinction. The Biosimilar Red Tape Elimination Act is consistent with FDA’s science-based recommendation and represents an important step toward building confidence and streamlining patient access to biosimilar medicines.

We look forward to continuing to work with you, as leaders of the committees of jurisdiction, to achieve its enactment as soon as possible.

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