To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy, and for other purposes.
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Summary
Based on the bill's title, this measure would amend the Public Health Service Act to establish that biosimilar biological products do not require clinical studies assessing pharmacodynamics or comparative clinical efficacy as a default condition for licensure. The bill would modify regulatory standards for how the FDA evaluates biosimilar drugs, potentially streamlining the approval pathway by reducing required clinical testing.
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How your representatives voted
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