Expedited Access to Biosimilars Act
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Summary
This bill amends the Public Health Service Act to modify the clinical study requirements for FDA approval of biosimilar drugs. Specifically, it removes the automatic requirement that clinical studies assess immunogenicity, pharmacodynamics, or comparative clinical efficacy, instead making these assessments discretionary at the FDA's determination. The FDA may only require these assessments if it provides written justification to the applicant before the application is filed.
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