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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA

Rivista di Dermatologia e Malattie Sessualmente Trasmesse


Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
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Giornale Italiano di Dermatologia e Venereologia 2015 August;150(4):449-59

Copyright © 2015 EDIZIONI MINERVA MEDICA

lingua: Inglese

Biosimilar infliximab: an expert view

Genazzani A. 1, Altomare G. 2, Balato N. 3, Cusano F. 4, De Pità O. 5, Loconsole F. 6, Micali G. 7, Piaserico S. 8, Girolomoni G. 9

1 Ospedale A. Avogadro, Novara, Italy; 2 IRCCS Ospedale Galeazzi, Milan, Italy; 3 Università Federico II, Naples, Italy; 4 Azienda Ospedaliera G. Rummo, Benevento, Italy; 5 IDI, Rome, Italy; 6 Policlinico Universitario, Bari, Italy; 7 Policlinico Vittorio Emanuele, Catania, Italy; 8 Azienda Ospedaliera di Padova, Padua, Italy; 9 University of Verona, Verona, Italy


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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.

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giampiero.girolomoni@univr.it