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Expedited Access to Biosimilars Act
5/2/2025, 2:23 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.
Read the Full Bill
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 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of April 10, 2025
Bipartisan Support of Bill S 1414
Total Number of Sponsors
3Democrat Sponsors
0Republican Sponsors
3Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 1414
Primary Policy Focus
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.
Comments
Sponsors and Cosponsors of S 1414
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