S. 1414, the Expedited Access to Biosimilars Act, advanced out of committee on July 22, 2026.
S. 1414 — Expedited Access to Biosimilars Act
What it does
This bill removes the requirement that biosimilar drugs (cheaper copies of expensive biologic medicines) must undergo clinical studies testing for immunogenicity (immune system reactions), pharmacodynamics (how the drug affects the body), or comparative clinical efficacy (whether it works as well as the original). Instead, the FDA may only require these studies in rare cases, and only if it notifies the applicant in writing before they file. The effect is to speed up and cheapen biosimilar approval by eliminating safety and efficacy testing that currently protects patients.
Quorum's transparency scan gave Expedited Access to Biosimilars Act a high transparency warning.
What happens next
S. 1414 advanced out of committee. Next stop: a floor vote.
Who is behind it
Filed by Rand Paul. Cosponsored by Maggie Hassan and Mike Lee.