Expedited Access to Biosimilars Act

Clearer rules for biosimilar approvals

If enacted, this bill would change FDA rules for biosimilar drug approvals. Sponsors would need an assessment of pharmacokinetics and immunogenicity. The FDA would be able to require extra clinical studies that test pharmacodynamics or comparative efficacy only after giving a written determination to the sponsor. That written determination must appear in development meeting minutes or be provided within 60 days after an application is filed. The FDA could not add new study requirements later unless the sponsor agrees or the agency provides a detailed scientific justification and, if requested, holds a development meeting. These rules would apply only to applications filed on or after the date of enactment.