Extrapolation

Extrapolation is a scientific and regulatory principle7
The FDA has determined that extrapolation was appropriate for INFLECTRA with regard to Remicade® indications that were not studied.
  • Extrapolation is not automatic
  • Starts after establishing biosimilarity in an indication held by the reference product
  • Comparative clinical studies conducted in the selected indications may help support extrapolation to other indications, based on totality of scientific and clinical evidence
Extrapolation Standards: INFLECTRA extrapolation of clinical data in RA and AS
Standards of evaluation met by INFLECTRA3
Biosimilar guidance Scientific justification
Mechanism of action (MOA) for each indication
  • Consistent pathogenesis across indications 3
  • Common MOA across indications 3
  • Comparative structural and functional assays support biosimilarity and similar MOA 3
PK and biodistribution in different populations
  • Well-characterized linear PK across clinical indications 1
Immunogenicity in different populations
  • Similar immunogenicity and immunogenicity-related safety in studied populations 3
Expected toxicities in indicated population
  • Well-characterized Remicade safety profile across indications 3
  • Similar safety in sensitive populations 3
Other factors that may affect safety or efficacy
  • None determined 3