Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.

Abstract

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.

• Authors: Prasan Deep Rath, Der-Yuan Chen, Jieruo Gu, Vivian W Y Lee, Nizar Abdulateef Al Ani, Khalid Shirazy, Lyndon Llamado
• Journal: International journal of rheumatic diseases (Int J Rheum Dis) Vol. 22 Issue 1 Pg. 9-24 (Jan 2019) ISSN: 1756-185X [Electronic] England
• PMID: 30338644 (Publication Type: Journal Article, Review)
• Copyright: © 2018 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Chemical References

• Antirheumatic Agents
• Biological Products
• Biosimilar Pharmaceuticals
• Tumor Necrosis Factor-alpha

Topics

• Antirheumatic Agents (adverse effects, classification, therapeutic use)
• Asia
• Australia
• Biological Products (adverse effects, classification, therapeutic use)
• Biosimilar Pharmaceuticals (adverse effects, classification, therapeutic use)
• Drug Approval
• Drug Development (legislation & jurisprudence, methods)
• Government Regulation
• Humans
• Patient Safety
• Policy Making
• Practice Guidelines as Topic
• Rheumatic Diseases (diagnosis, drug therapy, immunology)
• Rheumatology (legislation & jurisprudence, methods)
• Risk Assessment
• Terminology as Topic
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors, immunology)