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
Regulatory Pathway graphic
Regulatory Pathway graphic
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