S. 1414Introduced

Expedited Access to Biosimilars Act

What this bill does

Modifies FDA biosimilar approval requirements by generally removing mandatory clinical efficacy studies and changing review procedures for biosimilar applications

Key points
  • Amend biosimilar study requirements
  • Modify FDA review assignment
  • Allow FDA to require efficacy studies

Where it stands

Status
Introduced
Latest action
2026-07-27 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.

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About these signals

Methodology

Impact and Momentum are relative discovery aids calculated by Legislation Lemur. They help you scan the congressional record; they are not predictions, endorsements, ideological ratings, or measures of policy importance.

Impact ScoreOverall observed legislative footprint and accumulated activity.
MomentumHow recently active or changing the bill appears in available data.