Expedited Access to Biosimilars Act

This bill modifies requirements for approving biosimilar drugs (follow-on versions of biologic medicines). It removes previous mandatory assessments of immunogenicity or clinical efficacy for biosimilar licensure, instead allowing the FDA to require such studies only when the agency provides written justification to the applicant. The change applies to new biosimilar applications submitted after the bill's enactment. It directly affects drug manufacturers seeking FDA approval for biosimilars and the FDA's review process, aiming to streamline approvals while maintaining safety standards.