Expedited Access to Biosimilars Act aims to streamline the approval process for biosimilars by removing certain clinical study requirements.

The Expedited Access to Biosimilars Act modifies the Public Health Service Act to exclude the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy from clinical studies needed for biosimilar licensure. This change is intended to expedite the approval process for biosimilars, potentially making them more accessible. The Act allows the Secretary to require these assessments if justified, but mandates prior notice to the applicant.

Expedited Access to Biosimilars Act aims to streamline the approval process for biosimilars by removing certain clinical study requirements.

The Expedited Access to Biosimilars Act modifies the Public Health Service Act to exclude the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy from clinical studies needed for biosimilar licensure. This change is intended to expedite the approval process for biosimilars, potentially making them more accessible. The Act allows the Secretary to require these assessments if justified, but mandates prior notice to the applicant.