Biosimilar Drugs: Speeding Up Approval for Cheaper Medicines
The Senate placed this bill on its legislative calendar on July 27, 2026, after it cleared the committee stage. It is now waiting for the full Senate to schedule a floor vote. The bill has not moved since July 27, 2026.
This bill has support from both Republicans and Democrats. Since it has already passed through a major Senate committee, it has a strong chance of being voted on by the full Senate.
Scores run from -100 (strongly harmful) to +100 (strongly beneficial) for each group, combining impact, certainty, scope, and duration ratings of 1-5. How impact scoring works
Smaller biotech and generic drug manufacturers developing biosimilars face high costs from extensive clinical trials. By limiting when the FDA can require additional studies on immunogenicity, pharmacodynamics, or comparative efficacy, this bill could lower development costs and barriers to entering the biosimilar market.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
The bill is now on the schedule for the full chamber to consider. It's in line for debate and a vote.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
The Expedited Access to Biosimilars Act (HR 9661/S 1414) would codify that comparative clinical efficacy and pharmacodynamic studies are not the default expectation for biosimilar licensure, preserving FDA authority to require them only when scientifically warranted to reduce development costs.
The House Energy and Commerce Committee approved the Expedited Access to Biosimilars Act, a bipartisan bill to streamline the regulatory pathway. The legislation aims to eliminate unnecessary clinical studies that currently delay the entry of lower-cost biological medicines into the market.
The Senate HELP Committee unanimously approved the Expedited Access to Biosimilars Act. The bill seeks to modernize the FDA's approval process by allowing the agency to waive certain clinical trials when existing scientific evidence is sufficient to prove a drug's safety and effectiveness.
No votes recorded for this bill yet.
Document Type
Congressional Bill
Official Title
Expedited Access to Biosimilars Act
Analysis generated by AI. Always verify with official sources.