中国获批上市生物类似药的特征及适应症对比分析

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

关键词:  生物药  生物类似药  适应症  集中采购

Key words:  Biological products  Biosimilars  Indications  Centralized procurement

摘要:

目的 分析中国获批上市的生物类似药的特征，对生物类似药与其参照药的适应症、疗效和安全性进行对比，为促进企业研发生产、完善生物药集采规则和加强生物类似药监管提供参考。方法 通过公开数据库，对获批上市生物类似药的特征进行分析。梳理原研生物药的国内外获批适应症，对生物类似药与其参照药的国内获批适应症、疗效和安全性进行对比分析。结果 2019年1月至2025年4月，共有57个生物类似药获批上市，覆盖7个治疗领域。获批上市生物类似药从申请至批准上市的中位数时间为1.40年、平均时间为1.47年。57个获批上市的生物类似药中共有38个药品纳入医保目录，占比为66.67%，2个药品纳入省级集采，占比为3.51%。14种原研生物药的国内外获批适应症存在差异，占比为82.35%；44个生物类似药与其参照药获批适应症存在差异，占比为77.19%。99.04%的文献结果显示生物类似药与其参照药疗效相似，96.60%的文献结果显示生物类似药与其参照药安全性相似。结论 中国获批上市的生物类似药数量不断上升，但仍存在生物类似药部分品种研发进展缓慢、治疗领域结构化不足、审评审批时间稳定性不足、医保与集采纳入比例有待提高等问题。未来需从鼓励生物类似药研发、优化生物类似药审评审批流程、制定符合生物类似药特点的医保与集中采购规则、积极推动生物技术创新等方面系统推进，促进生物类似药的研发与合理使用。

Abstract:

Objective To analysis of the characteristics of approved biosimilars in China and comparative analysis of approved indications, efficacy, and safety between biosimilars and their reference products. To inform industry R&D strategies, improve biologic procurement policies, and strengthen biosimilar regulatory oversight. Methods Through the open database, the main characteristics of approved biosimilars were analyzed. Comprehensive mapping of domestic and international approved indications for reference biologics and Comparative analysis of domestically approved indications, efficacy, and safety between biosimilars and their reference biologics. 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. CONCLUSIONS 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.