Comparative Analysis of the Characteristics and Indications of Approved Biosimilars in China

OBJECTIVE To analyze the characteristics of approved biosimilars in China and to compare the approved indications, efficacy, and safety between biosimilars and their reference products. To provide a reference for promoting industry R&D strategies, improving biologics procurement policies, and strengthen biosimilar regulatory oversight.

METHODS Through the public databases, the main characteristics of approved biosimilars were analyzed. Comprehensive mapping of domestic and international approved indications for products was conducted, and comparative analysis of domestically approved indications, efficacy, and safety between biosimilars and their reference products was performed.

RESULTS From January 2019 to April 2025, a total of 57 biosimilar products received marketing authorization, spanning 7 therapeutic categories. The median approval time for biosimilars from application to marketing authorization was 1.40 years, with a mean approval time of 1.47 years. Among the 57 approved biosimilars, 38(66.67%) were included in the National Reimbursement Drug List, while 2(3.51%) were incorporated into provincial centralized procurement programs. Discrepancies in approved indications were observed between domestic and international approvals for 14 originator biologics(82.35%), and between 44 biosimilars and their reference products(77.19%). The literature results indicate that 99.04% of studies reported comparable efficacy between biosimilars and their reference products, while 96.60% of studies concluded that biosimilars exhibited a similar safety profile to their reference counterparts.

CONCLUSION The biosimilar market in China demonstrates sustained growth in marketing authorizations. However, several challenges persist: delayed R&D progress for certain biosimilar products, inadequate diversification across therapeutic areas, inconsistent regulatory review timelines, and suboptimal inclusion rates in national reimbursement and centralized procurement programs. Future efforts should adopt a systematic approach that includes incentivizing the development of biosimilars, optimizing the regulatory review and approval processes, establishing medical insurance and centralized procurement rules tailored to the characteristics of biosimilars, and actively promoting innovation in biotechnologies, so as to facilitate the advancement and rational use of biosimilars.