Expedited Access to Biosimilars Act

[AI summary unavailable — showing source text] [Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 1414 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 1414 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. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES April 10, 2025 Mr. Paul introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ 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. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Expedited Access to Biosimilars …