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

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 prese

SUBMITTER: Scheinberg M 

PROVIDER: S-EPMC6152448 | biostudies-literature | 2018 Aug/Sep

REPOSITORIES: biostudies-literature