Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

MAbs
Morton ScheinbergIra Jacobs

Abstract

Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of "non-comparable biotherapeutics" (also known as "intended copies"), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Citations

Jan 4, 2020·Pharmaceutical Patent Analyst·Rodrigo González-Ramírez, Gilberto Castañeda-Hernández
Feb 19, 2020·CA: a Cancer Journal for Clinicians·Javier CortesJoaquín Arribas
May 31, 2019·Pharmacoepidemiology and Drug Safety·Gilberto Castañeda-HernándezCarlos Pineda
Oct 22, 2019·Arquivos De Gastroenterologia·Abel Botelho QuaresmaPaulo Gustavo Kotze

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay

Clinical Trials Mentioned

NCT02268045
NCT02069704
NCT03293654
NCT03296163

Software Mentioned

Celltrion
ANVISA

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