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Yazhen Kou on Muck Rack

Yazhen Kou

As seen in: Cell Press
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Articles

Biosimilars: navigating the regulatory maze across two worlds

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By Wu He, Kaikun Wei, Yazhen Kou, Hongjin Kan
| Cell Press Verified
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.
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