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Anti‐tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region
Author(s) -
Rath Prasan Deep,
Chen DerYuan,
Gu Jieruo,
Lee Vivian W. Y.,
Al Ani Nizar Abdulateef,
Shirazy Khalid,
Llamado Lyndon
Publication year - 2019
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.13371
Subject(s) - medicine , biosimilar , rheumatology , perspective (graphical) , tumor necrosis factor alpha , asia pacific , oncology , international trade , artificial intelligence , business , computer science
Although anti‐tumor necrosis factor ( TNF ) agents have greatly improved the management of rheumatic diseases, their cost limits access to many patients throughout the world. As a result, patients and clinicians have turned to biosimilars to provide similar efficacy at a lower cost. Many of the regulatory guidelines in the Asia Pacific region are largely based on those of the European Medicines Agency and the World Health Organization; however, there are variations between countries. Additionally, in some countries, intended copies are available that were approved prior to the development of guidelines and have not fulfilled the requirements of a biosimilar. We review the various regulatory requirements for biosimilars in the Asia Pacific region, the anti‐ TNF biosimilars and intended copies approved in the region, and whether clinical data are available for these agents. We discuss concerns about the need for additional regulations and education, and we provide recommendations for a multidisciplinary pharmacovigilance approach that closely monitors the safety of biosimilar use.