Biosimilars: navigating the regulatory maze across two worlds

The impending loss of market exclusivity for established biologic products creates a lucrative market opportunity for biosimilars. However, complex and variable regulatory requirements between regions present challenges to developers. Understanding the regulatory differences between two major market...

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Bibliographic Details
Published in:Trends in biotechnology (Regular ed.) 2023-07, Vol.41 (7), p.847-850
Main Authors: Wei, Kaikun, Kou, Yazhen, Kan, Hongjin, He, Wu, Li, Jin, Guo, Xinjun
Format: Article
Language:English
Subjects:
Bioequivalence
Biological products
biosimilar
Biosimilar Pharmaceuticals
Breast cancer
Cancer therapies
Case studies
China
Clinical trials
Communication
EMA
Europe
HLX02
Metastasis
NMPA
Patients
Registration
regulation
Regulatory reform
trastuzumab
Citations: Items that this one cites
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Description
Summary:The impending loss of market exclusivity for established biologic products creates a lucrative market opportunity for biosimilars. However, complex and variable regulatory requirements between regions present challenges to developers. Understanding the regulatory differences between two major markets, Europe and China, will expedite entry into these key markets.
ISSN:0167-7799
1879-3096
DOI:10.1016/j.tibtech.2023.02.007