A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names

doi:10.13523/j.cb.1907011

China Biotechnology

2020, Vol. 40

Issue (1-2): 154-165 DOI: 10.13523/j.cb.1907011

Orginal Article

A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names

CAO Meng^1,²,ZHAO Yu-hao^1,³,GUO Zhong-ping^1,^*(

)

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.

Key words： Bio-therapeutics INN Approval Targets Indications Advanced biological products

Received: 05 July 2019 Published: 27 March 2020

ZTFLH:

Q819

Corresponding Authors: Zhong-ping GUO E-mail: guozp303@163.com

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Cite this article:

CAO Meng,ZHAO Yu-hao,GUO Zhong-ping. A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names. China Biotechnology, 2020, 40(1-2): 154-165.

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https://manu60.magtech.com.cn/biotech/10.13523/j.cb.1907011 OR https://manu60.magtech.com.cn/biotech/Y2020/V40/I1-2/154

Fig.1 Development process and distribution trends of the INNs for bio-therapeutics and small molecule drugs

Fig.2 Development process and distribution trends of INNs in four main biologic product categories

Table 1 Pharmacological classifications and numbers of bio-therapeutics

Fig.3 Pharmacological classification chart of bio-therapeutics

Fig.4 Development history of the targets for monoclonal antibodies (a)1991~2008 (b) 2009~2018

Fig.5 Development history of the targets for fusion proteins

Fig.6 Development history of the targets for gene therapy products

Fig.7 Development history of the targets for cell therapy products

Table 2 INN number of the monoclonal antibodies/fusion proteins targeting the cluster of differentiation classes

Table 3 INN number of the monoclonal antibodies/fusion proteins targeting the tumor necrosis factor classes

Table 4 INN number of the monoclonal antibodies/fusion proteins targeting the interleukin classes

Table 5 Statistics of highly concentrated targets for antibodies and the marketed products related

Table 6 Statistics of highly concentrated targets for fusion proteins and the marketed products related

Table 7 Distribution of the marketed bio-therapeutics in INN population

Table 8 Approved bio-therapeutics in Europe, America, Japan and China


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