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.

This bill would change the Public Health Service Act to make it so that when a company applies for approval of a biosimilar product (a medicine that is very similar to one already approved), the approval process would not normally require certain types of studies, specifically studies looking at how the drug works in the body or how well it works compared to the original product. No official summary is available for this bill.

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