Immune-mediated inflammatory diseases share several pathogenic pathways and
this pushes sometimes to extrapolate from one disease or indication to others. A biosimilar
can be defined as a biotherapeutic product which is similar in terms of quality, safety, and efficacy
to an already licensed reference biotherapeutic product. We review the substrate for
extrapolation, the current approval process for biosimilars and the pioneering studies on
biosimilars performed in rheumatoid arthritis patients. A biosimilar has the same amino acid
sequence as its innovator product. However, post-translational modifications can occur and
the current analytical techniques do not allow the final structure. To test the efficacy in one
indication, a homogeneous population should be chosen and immunogenicity features are essential
in switching and interchangeability. CT-P13 (Remsima™; Inflectra™) is a biosimilar
of reference infliximab (Remicade®). It meets most of the requirements for extrapolation.
Nevertheless, in inflammatory bowel diseases (IBD) we need more studies to confirm the postulates
of extrapolation from rheumatoid arthritis and ankylosing spondylitis to IBD. Furthermore,
an effective pharmacovigilance schedule is mandatory to look for immunogenicity and
Keywords: Biosimilars, inflammatory bowel diseases, Crohn's disease, ulcerative colitis, biologics, infliximab.
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