Summary

Allows the Secretary to require that a biosimilar licensure application include clinical assessments of immunogenicity, pharmacodynamics (PD), or comparative clinical efficacy when the Secretary decides they are needed. The Secretary may only impose such requirements if the applicant receives timely written notice and a written justification no later than the earliest date the applicant could file the application. The rule applies to biosimilar (351(k)) applications submitted on or after the law takes effect.

Key Points

• Gives the Secretary authority to require immunogenicity, PD, or comparative clinical efficacy assessments for biosimilar licensure.
• The Secretary exercises this authority at their discretion, not automatically for all applications.
• Applicants must get written notice and a written justification before the Secretary can impose such study requirements.
• The notice/justification must arrive no later than the earliest date the applicant may file the 351(k) application.
• The rule applies only to biosimilar applications submitted on or after enactment.
• Could increase development time and cost for some biosimilar applicants when extra clinical studies are required.
• Provides regulators more flexibility to demand clinical evidence that addresses safety or effectiveness concerns.
• Advance notice requirement improves predictability but does not remove regulatory uncertainty about possible study demands.

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