Biomaterial Database

Update on Biosimilars in Asia. 2017

Wen-Chan Tsai

School of Medicine Kaohsiung Medical University, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou 1st Road, Kaohsiung, Taiwan. d10153@ms14.hinet.net.

OBJECTIVE This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RESULTS The use of biologics revolutionized the treatment of various diseases. However, the high cost of biologics remained unaffordable for most Asian patients and increases the financial burden of Asian governments. The development of biosimilars provides the best solution for this predicament. A great boom of biosimilars is developing in Asia. Hundreds of biopharmaceutical companies have established their manufacturing facilities and provide affordable products for Asian patients. Regulation guidelines and international harmonization are evolving. Better manufacturing quality and post-market pharmacovigilance are needed in Asia despite the rapid evolution of biosimilar development.

UI	MeSH Term	Description	Entries
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001208	Asia	The largest of the continents. It was known to the Romans more specifically as what we know today as Asia Minor. The name comes from at least two possible sources: from the Assyrian asu (to rise) or from the Sanskrit usa (dawn), both with reference to its being the land of the rising sun, i.e., eastern as opposed to Europe, to the west. (From Webster's New Geographical Dictionary, 1988, p82 & Room, Brewer's Dictionary of Names, 1992, p34)
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval
D055808	Drug Discovery	The process of finding chemicals for potential therapeutic use.	Drug Prospecting,Discovery, Drug,Prospecting, Drug
D059451	Biosimilar Pharmaceuticals	Biological products that are imitations but not exact replicas of innovator biological products.	Biosimilar,Biosimilars,Follow-on Biologics,Subsequent Entry Biologics,Biologics, Follow-on,Biologics, Subsequent Entry,Follow on Biologics,Pharmaceuticals, Biosimilar