Expedited Access to Biosimilars Act aims to streamline the approval process for biosimilar biological products by limiting additional clinical.

The Expedited Access to Biosimilars Act amends the Public Health Service Act to change the default expectation for the licensure of biological products as biosimilars. It specifies that clinical studies assessing pharmacodynamics or comparative clinical efficacy are not required unless the Secretary of Health and Human Services determines they are necessary. The Act also repeals a requirement for additional reviews of biosimilar biological products. These changes aim to expedite the approval process for biosimilars, potentially increasing their availability and affordability.

Expedited Access to Biosimilars Act aims to streamline the approval process for biosimilar biological products by limiting additional clinical.

The Expedited Access to Biosimilars Act amends the Public Health Service Act to change the default expectation for the licensure of biological products as biosimilars. It specifies that clinical studies assessing pharmacodynamics or comparative clinical efficacy are not required unless the Secretary of Health and Human Services determines they are necessary. The Act also repeals a requirement for additional reviews of biosimilar biological products. These changes aim to expedite the approval process for biosimilars, potentially increasing their availability and affordability.