Biosimilars: navigating the regulatory maze across two worlds |
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| Institution: | 1. Office for Pharmaceutical Science of Biological Products, Center for Drug Evaluation, National Medical Products Administration, Beijing, China;2. Shanghai Henlius Biotech, Inc., Shanghai, China |
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| Abstract: | 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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