1. Biosimilar infliximab: an expert view.
- Author
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Genazzani A, Altomare G, Balato N, Cusano F, De Pità O, Loconsole F, Micali G, Piaserico S, and Girolomoni G
- Subjects
- Antibodies, Monoclonal chemistry, Biosimilar Pharmaceuticals chemistry, Drug Approval, Humans, Infliximab chemistry, Italy, Molecular Weight, Antibodies, Monoclonal therapeutic use, Biosimilar Pharmaceuticals therapeutic use, Infliximab therapeutic use
- Abstract
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.
- Published
- 2015