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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Veröffentlicht in:	Trends in biotechnology (Regular ed.) 2023-07, Vol.41 (7), p.847-850
Hauptverfasser:	Wei, Kaikun, Kou, Yazhen, Kan, Hongjin, He, Wu, Li, Jin, Guo, Xinjun
Format:	Artikel
Sprache:	eng
Schlagworte:	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
Online-Zugang:	Volltext
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Beschreibung
Zusammenfassung:	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