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Expedited Access to Biosimilars Act

7/28/2026, 11:03 AM

Summary of Bill S 1414

This bill, introduced in the 119th Congress, aims to amend the Public Health Service Act by removing the requirement for clinical studies assessing immunogenicity, pharmacodynamics, or comparative clinical efficacy for licensure of biological products as biosimilar.

Current Status of Bill S 1414

Bill S 1414 is currently in the status of Bill Introduced since April 10, 2025. Bill S 1414 was introduced during Congress 119 and was introduced to the Senate on April 10, 2025.  Bill S 1414's most recent activity was Placed on Senate Legislative Calendar under General Orders. Calendar No. 520. as of July 27, 2026

Bipartisan Support of Bill S 1414

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
2
Democrat Cosponsors
1
Republican Cosponsors
1
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill S 1414

Primary Policy Focus

Health

Alternate Title(s) of Bill S 1414

A bill to amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
A bill to amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.

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