Biosimilars are
biologic medical products whose active
drug substance is made by a living organism or derived from it. The term is used to describe a subsequent version of an innovator
biopharmaceutical product aiming at approval following patent expiry on the reference product.
Biosimilars of monoclonal need to demonstrate similar but not identical quality of nonclinical and clinical attributes. Not all data of the originator product need to be recapitulated, as large numbers of patient-years of exposure data are already available. Thus,
biosimilar development is largely based on the safety profiles of the originator product. The evaluation of biosimilarity includes immunogenicity attributed risks.
CT-P13 (Remsima™/Inflectra™, Celltrion/Hospira), a
biosimilar of the innovator
drug infliximab (INF), was the first approved complex
biosimilar monoclonal antibody in the EU, within the framework of WHO, EMA and US FDA
biosimilar guidelines.
CT-P13 has shown analytical and nonclinical features highly similar to INF including pharmacokinetics, efficacy, safety and immunogenicity profiles in
ankylosing spondylitis and
rheumatoid arthritis. The objective of this article is to highlight the recent
biosimilar development and to review the results from the studies PLANETRA and PLANETAS, which have supported the approval of
CT-P13 for several indications.