Sponsors (3)
The bill trades increased pre-approval clinical data requirements to boost confidence in biosimilar safety for higher development costs, delayed market competition, and regulatory uncertainty that could keep prices higher and discourage developers.
Patients with chronic conditions and their clinicians/hospitals will have greater confidence in biosimilar safety and effectiveness, and may experience fewer unexpected adverse reactions because sponsors would need additional immunogenicity or efficacy clinical assessments before approval.
Biosimilar developers—especially small companies—will face higher development costs and longer approval timelines, likely delaying market entry of lower‑cost biosimilars and keeping drug prices higher for patients who rely on them.
Granting regulators broad, discretionary authority to require additional unspecified data creates regulatory uncertainty that could discourage investment and competition in the biosimilars market.
Based on analysis of 2 sections of legislative text.
Allows HHS to require immunogenicity, pharmacodynamic, or comparative efficacy assessments in biosimilar clinical studies, with required written notice and justification before filing; applies to new 351(k) applications.
Allows the HHS Secretary to require certain clinical assessments (immunogenicity, pharmacodynamics, or comparative clinical efficacy) in clinical studies submitted to license a biologic as a biosimilar, but only if the Secretary gives the applicant written notice and a written justification no later than the earliest date the applicant may file the 351(k) application. The rule applies to biosimilar applications submitted on or after the law's enactment.
Official title: Amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
Introduced April 10, 2025 by Rand Paul · Last progress April 10, 2025