目的:探讨开展生物药集采工作的特点、难点与政策进展。方法:基于文献综述,全面分析生物药集采的特点与难点,对生物药集采的政策思路进行分析。结果:生物药集采面临三个主要的困难因素,即临床可替代性问题、适应症难以自然外推问题以及产能保障问题。这些问题需要在政策设计中予以全面的考量,而已开展的胰岛素专项集采在上述方面进行了有益的探索,积累了经验。结论:生物药带量集采应根据该类药品的特点,进行科学合理的政策设计和实施。
Abstract
Objective: The paper attempts to explore the features, difficulties and policy progress of centralized purchasing of biological drugs with target quantity.Methods: Using the methods of literature review, the characteristics and difficulties of centralized purchasing of biological drugs were comprehensively analyzed, and the policy frame of the centralized purchasing of biological drugs were analyzed and elaborated.Results: Centralized purchasing of biological drugs with target quantity faces three major obstacles, i.e. clinical substitutability, the difficulty of natural extrapolation of indications and supply capacity problems. The insulin-specialized centralized procurement has conducted useful explorations and accumulated experience.Conclusion: Policies of the centralized purchasing of biological drugs should be scientifically and rationally designed and implemented based on the characteristics of biological drugs.
关键词
生物药 /
带量集采 /
政策设计
Key words
biological drugs /
purchasing with quantity /
policy design
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 朱圣庚, 徐长法. 生物化学[M]. 4版. 北京: 高等教育出版社, 2017; 4-5, 147.
[2] 周爱萍. 生物治疗药物和生物类似药研究进展[J].中国新药杂志,2017,26(3):296-299.
[3] 张锴婷,陈乃涵.生物药在肿瘤治疗领域的临床研究进展[J].中国临床药理学与治疗学,2020,25(1):32-43.
[4] 国家食品药品监督管理总局.生物类似药研发与评价技术指导原则:试行[EB/OL]. (2015-02-28)[2022-02-10].http://www.nmpa.gov.cn/WS04/CL2138/300003.html.
[5] 曹萌,赵宇豪,郭中平 .从国际非专利名称纵观全球生物药发展[J]. 中国生物工程杂志, 2020, 40(1/2): 154-165.
[6] 王海学, 陆国才, 张子腾等. 生物类似药的免疫原性研究与评价技术思考[J]. 中国药学杂志, 2015, 50(6):483-489.
[7] Pineda C, Castañeda Hernández G, Jacobs IA, et al.Assessing the Immunogenicity of Biopharmaceuticals[J]. BioDrugs, 2016, 30(3):195-206.
[8] Declerck Paul, Danesi Romano, Petersel Danielle, et al.The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects[J]. Drugs, 2017, 77(6): 671-677.
[9] 里扎·阿德列提别克,蒋蓉,邵蓉.欧盟地区生物类似药可互换性政策与管理实践研究[J].中国医药工业杂志,2019,50(11):1361-1366.
[10] 胡晓敏,宗英,高晨燕等.FDA证明生物类似药与参照药可互换的考虑要点[J].中国新药杂志,2017,26(15):1767-1772.
[11] 张彦彦,王晓东,沈梦娟等.各国生物类似药沟通交流机制及生物类似药可互换性对比研究及建议[J].现代药物与临床,2019,34(4):916-920.
[12] Bridges SL, White DW, Worthing AB, et al.The Science Behind Biosimilars: Entering a New Era of Biologic Therapy[J].Arthritis Rheumatol, 2018, 70(3): 334-344.
[13] 徐子悦,韩晟,管晓东等.生物类似药临床用药互换的思考与建议[J].中国新药杂志,2021,30(17):1554-1558.
[14] 国家药品监督管理局药品审评中心. 生物类似药相似性评价和适应症外推技术指导原则[EB/OL].(2021-02-18)[2022-02-10]. https://www.cde.org.cn/main/news/viewInfoCommon/ d92c6507a57bee9ccfc5baa1ee87fda9.
[15] 史策, 虞骥, 高栋, 等.单抗制备的过程模拟和经济性分析[J].化工学报, 2018, 69(7): 3198-3207.
[16] 陈烨,丁锦希,郝丽等.集中带量, 还是挂网议价采购:生物类似药采购模式研究[J].中国医药工业杂志,2020,51(4):539-544.
[17] 夏金彪. 胰岛素成为国家集采生物药的突破口[N]. 中国经济时报,2021-11-30(002).
[18] 黄晶. 胰岛素集采突破生物药重围[N]. 医师报,2021-12-23(B01).
[19] 陶立波. 生物药带量集采的权衡与考量[N]. 医药经济报,2021-12-06(F02).
[20] Hu X, Zhang L, Dong Y, et al.Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review[J]. F1000Res. 2018, 7:477.