Module 9 2024

05/09/2024

Immunogenicity

• Immunogenicity usually secondary endpoint • Sometimes FDA will require a formal immunogenicity study • “a one -sided design will ordinarily be adequate to compare clinical immunogenicity of the proposed product and reference product.” • Setting margin can be challenging as one cannot rely on historical data – need to consider adaptive trials Kozlowski et. al. “the FDA will evaluate immunogenicity in a risk- based manner.”

The Organisation for Professionals in Regulatory Affairs

45

THERAPEUTIC EQUIVALENCE

The Organisation for Professionals in Regulatory Affairs

46

23