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Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment
Joint Authors
Bas, Tomas Gabriel
Oliu Castillo, Carolina
Source
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-12, 12 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-04-24
Country of Publication
Egypt
No. of Pages
12
Main Subjects
Abstract EN
The development of biological products has experienced continuous growth over the past three decades.
The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world.
This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia.
The literature suggests that biosimilars are comparable but not identical to the reference product.
They are not a generic version of an innovative product and do not ensure therapeutic equivalence.
Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated.
Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).
American Psychological Association (APA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. 2016. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International،Vol. 2016, no. 2016, pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
Modern Language Association (MLA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International No. 2016 (2016), pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
American Medical Association (AMA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International. 2016. Vol. 2016, no. 2016, pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1098258