On July 7, 2025, R Street Institute joined 38 other organizations in supporting the Biosimilar Red Tape Elimination Act (S. 1954). The legislation aims to remove the distinction between biosimilars and interchangeable biosimilars, thereby increasing patient access to essential medications and reducing healthcare costs.
Since their market introduction in 2015, biosimilars have saved over $36 billion and contributed to more than 2.6 billion days of patient therapy without clinically meaningful differences in safety or outcomes. Competition from biosimilars has also expanded patient access by nearly 500 million days of therapy.
However, confusion persists due to the statutory distinction between biosimilars and interchangeable biosimilars. The FDA has consistently stated there is no scientific difference between the two and recommended that Congress eliminate this outdated distinction. The proposed act aligns with the FDA’s recommendation and seeks to enhance confidence and streamline access to these medicines.
The letter expressing support for this act was addressed to Chairman Cassidy, Chairman Guthrie, Ranking Member Pallone, and Ranking Member Sanders. It acknowledges their leadership in reintroducing the act and expresses eagerness for its enactment.