Expedited Access to Biosimilars Act

This bill, known as the Expedited Access to Biosimilars Act, aims to modify the requirements for the licensure of biosimilar biological products under the Public Health Service Act. Its primary purpose is to codify that the default expectation for biosimilar licensure does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy. This change is intended to streamline the approval process for biosimilars, potentially accelerating their availability to patients. The legislation specifies that the Secretary may only require additional clinical studies, including those assessing pharmacodynamics or efficacy, if such studies are determined to be necessary to demonstrate biosimilarity. If required, the Secretary must provide written notice of this determination, including justification, either at the time of a biosimilar product development meeting request or within 60 days of an application submission. These amendments will apply to applications submitted on or after the date of the Act's enactment.