Expedited Access to Biosimilars Act

This bill proposes significant changes to the clinical study requirements for the licensure of biosimilar biological products under the Public Health Service Act. It amends Section 351(k)(2)(A) to specify that clinical studies for biosimilar approval shall not be required to include assessments of immunogenicity, pharmacodynamics, or comparative clinical efficacy. Despite this general removal of requirements, the Secretary retains discretion to mandate these specific assessments if deemed necessary. Such a requirement can only be imposed if the Secretary provides the applicant with written notice and a detailed justification for the determination by the earliest date the application can be filed. This legislative change aims to potentially accelerate the approval process for biosimilars by reducing the scope of required clinical trials, thereby facilitating quicker market access for these products.