Extrapolation is a scientific and regulatory principle25.

  • 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

Principles of Extrapolation

Inflectra® has demonstrated comparable efficacy and safety to Remicade® in rigorous clinical studies for RA and AS and, via extrapolation is licensed for all of the same clinical indications as Remicade®1,3.

EMA Guidlines: Extrapolation

 

Prescribing Information 

Inflectra® Summary of Product Characteristics   |   Legal Category: POM  Basic NHS Price: 1 vial £377.66

RA, Rheumatoid arthritis; AS, Ankylosing spondylitis; EMA, European Medicines Agency; mAb, Monoclonal antibody.

 

PP-IFA-GBR-0292. December 2018