Biosimilars: navigating the regulatory maze across two worlds

Kaikun Wei; Yazhen Kou; Hongjin Kan; Wu He; Jin Li; Xinjun Guo

doi:10.1016/j.tibtech.2023.02.007

Biosimilars: navigating the regulatory maze across two worlds

Trends Biotechnol. 2023 Jul;41(7):847-850. doi: 10.1016/j.tibtech.2023.02.007. Epub 2023 Mar 14.

Authors

Kaikun Wei¹, Yazhen Kou², Hongjin Kan², Wu He², Jin Li³, Xinjun Guo³

Affiliations

¹ Office for Pharmaceutical Science of Biological Products, Center for Drug Evaluation, National Medical Products Administration, Beijing, China. Electronic address: weikk@cde.org.cn.
² Office for Pharmaceutical Science of Biological Products, Center for Drug Evaluation, National Medical Products Administration, Beijing, China.
³ Shanghai Henlius Biotech, Inc., Shanghai, China.

PMID: 36925315
DOI: 10.1016/j.tibtech.2023.02.007

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.

Keywords: EMA; HLX02; NMPA; biosimilar; regulation; trastuzumab.

MeSH terms

Biosimilar Pharmaceuticals*
China
Europe

Substances

Biosimilar Pharmaceuticals