Biosimilar infliximab: an expert view.
CT-P13, a biosimilar of infliximab, was the first biosimilar monoclonal antibody to be approved in both the European Union and Korea. As a monoclonal antibody, CT-P13 is a large molecule with a high molecular weight, and as such it differs from other biosimilars currently in the market. The comparability exercise for CT-P13, therefore, requires special consideration, as it was the first demonstration of biosimilarity between a biosimilar monoclonal antibody and its originator. This paper summarizes current regulations on the approval of biosimilars, describes the evidence leading to the approval of CT-P13, and discusses the potential role of this molecule in the Italian scenario on the basis of the view of a group of experts.
Ospedale A. Avogadro, Novara, Italy - giampiero.girolomoni@univr.it.
A
A
Genazzani
G
G
Altomare
N
N
Balato
F
F
Cusano
O
O
De Pità
F
F
Loconsole
G
G
Micali
S
S
Piaserico
G
G
Girolomoni
D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000627:therapeutic use*; D017277:Drug Approval; D006801:Humans; D000069285:Infliximab / Q000737:chemistry / Q000627:therapeutic use*; D007558:Italy; D008970:Molecular Weight
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab