Expedited Access to Biosimilars Act
The Expedited Access to Biosimilars Act, introduced in the Senate, would change the clinical study requirements for licensure of biological products as biosimilars under the Public Health Service Act. By default, it would remove the requirement to include assessments of immunogenicity, pharmacodynamics, or comparative clinical efficacy from the core clinical studies. Instead, biosimilar developers would need pharmacokinetic studies and safety/purity/potency data, and studies demonstrating safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought. The bill still allows the Secretary (FDA) to require immunogenicity, pharmacodynamics, or comparative efficacy in those studies, but only if the agency provides notice with a written justification by the earliest date the applicant may file for licensure. The changes would apply to biosimilar applications submitted after enactment. In short, the bill aims to speed biosimilar approvals and reduce the clinical data burden, while preserving a limited, discretionary pathway for the FDA to require additional assessments in justified cases.
Key Points
- 1Default: Biosimilar licensure under 351(k) would no longer automatically require assessments of immunogenicity, pharmacodynamics, or comparative clinical efficacy. Instead, the focus would be on pharmacokinetics and demonstrations of safety, purity, and potency, plus demonstration of safety, purity, and potency in at least one appropriate use scenario for which licensure is sought.
- 2Core requirements retained: Applicants must show safety, purity, and potency, and must demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed.
- 3Secretary’s discretionary authority: The FDA may determine that a biosimilar study must include assessments of immunogenicity, pharmacodynamics, or comparative clinical efficacy, but only pursuant to a notice-and-justification requirement.
- 4Notice-and-justification condition: The FDA may require those additional assessments only if it provides the applicant with a written justification by the earliest date the applicant may file the biosimilar application.
- 5Applicability: The changes apply to biosimilar applications submitted on or after the date of enactment; prospective only, not retroactive.