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
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.
RA, Rheumatoid arthritis; AS, Ankylosing spondylitis; EMA, European Medicines Agency; mAb, Monoclonal antibody.
PP-IFA-GBR-0292. December 2018