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.
journal_name
MAbsjournal_title
mAbsauthors
Scheinberg M,Pineda C,Castañeda-Hernández G,Zarbá JJ,Damião A,Arantes LH Jr,Jacobs Idoi
10.1080/19420862.2018.1484977subject
Has Abstractpub_date
2018-08-01 00:00:00pages
827-842issue
6eissn
1942-0862issn
1942-0870journal_volume
10pub_type
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