Orginal Article |
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A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names |
CAO Meng1,2,ZHAO Yu-hao1,3,GUO Zhong-ping1,*() |
1 Chinese Pharmacopoeia, Beijing 100061,China 2 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China 3 Shanghai Institute for Food and Drug Control, Shanghai 201203, China |
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Abstract Bio-therapeutics refer to the macromolecular biological products prepared by biotechnology and applied in disease treatment. Because of their high complexity/heterogeneity on aspects of structure and activity, the scientific and rigorous generic names for bio-therapeutics are fundamental for identifying effective drug substances and regulating their life cycle. The International Nonproprietary Names (INN) Program was established by the World Health Organization (WHO) and coordinated to be a global standardization system for assigning nonproprietary names to medicinal substances.The origin and development of the INN system in particular the biologics INN system were introduced, the INN categories, substances and marketing situation were also illustrated to reflect the development trend of bio-therapeutics. Through detailed data analysis, the development process of global bio-therapeutics as well as related bio-technology were presented and reviewed from multiple perspectives, which could be harnessed as important reference significance for the R&Ds, technical standards, clinical applications and regulatory strategy considerations.
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Received: 05 July 2019
Published: 27 March 2020
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Corresponding Authors:
Zhong-ping GUO
E-mail: guozp303@163.com
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