美国生物类似药的使用与医疗保险支付策略分析——基于Pfizer vs. Johnson案的思考 <sup>*</sup>

doi:10.13523/j.cb.20191212

中国生物工程杂志

2019, Vol. 39

Issue (12): 95-102 DOI: 10.13523/j.cb.20191212

行业分析

美国生物类似药的使用与医疗保险支付策略分析——基于Pfizer vs. Johnson案的思考 ^*

董心月,蒋蓉,里扎·阿德列提别克,邵蓉(

)

中国药科大学国家药物政策与医药产业经济研究中心南京 211198

The Clinical Use and Insurance of Biosimilars in the US ——Taking the Pfizer vs. Johnson Lawsuit as an Example

DONG Xin-yue,JIANG Rong,LIZHA Adelietibieke,SHAO Rong(

)

The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China

全文: PDF(849 KB) HTML

摘要：

近几年全球生物类似药发展如火如荼,各国出台积极政策响应与推动生物类似药的研发和应用,大型制药企业也通过一系列对生物医药公司的收购完成生物类似药研发先机的抢占。以Pfizer vs. Johnson案为研究对象,对美国生物类似药的保障政策、诉讼案件发展和系列焦点问题进行整体描述与深入分析。研究发现,来自原研企业的竞争压力及临床对生物类似药可替代性的质疑与保守态度,都在一定程度上对类似药的应用和推广构成威胁,而其价格优势和越来越明朗的政策环境使得生物类似药的未来可期。

关键词： 美国; 生物类似药; Pfizer; vs.; Johnson案; 临床可替代; 垄断

Abstract:

In recent years, the global development of biosimilars is in full swing. Governments have introduced a series of incentive policies to promote the development and application of biosimilars, in addition, large-scale pharmacy enterprises have also seized biosimilars’ market opportunities through the acquisition of other small and medium-sized biopharmaceutical companies. The Pfizer vs. Johnson lawsuit was taken as a research object, and the overall description of American biosimilars insurance policies, development process of litigation case and in-depth analysis of series focus issues were carried out. The study found that the competitive pressures from the original companies and the clinical conservative attitudes towards the substitutability of biosimilars threaten the application and promotion of biosimilars to a certain extent, while its price advantage and increasingly clear policy environment make the future of biosimilars promising.

Key words: US Biosimilars Pfizer vs. Johnson lawsuit Clinical substitutability Monopoly

收稿日期: 2019-04-13 出版日期: 2020-01-15

ZTFLH:

R951

基金资助: * 国家社会科学基金重大项目(15ZDB167)

通讯作者: 邵蓉 E-mail: shaorong118@163.com

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引用本文:

董心月,蒋蓉,里扎·阿德列提别克,邵蓉. 美国生物类似药的使用与医疗保险支付策略分析——基于Pfizer vs. Johnson案的思考 ^*[J]. 中国生物工程杂志, 2019, 39(12): 95-102.

DONG Xin-yue,JIANG Rong,LIZHA Adelietibieke,SHAO Rong. The Clinical Use and Insurance of Biosimilars in the US ——Taking the Pfizer vs. Johnson Lawsuit as an Example. China Biotechnology, 2019, 39(12): 95-102.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20191212 或 https://manu60.magtech.com.cn/biotech/CN/Y2019/V39/I12/95

表1 单一患者使用Remicade与Inflectra的成本对比概况

图1 Remicade美国上市后全球销售额、强生近10年销售收入及增长率(百万美元)

表2 “排他性合同”具体实施形式

表3 美国Medicare制度具体规则

图2 2017.01.01至2017.06.30英夫利昔单抗市场(报销量)

表4 Medicare B、Medicare D和Medicaid中生物类似药报销特殊规定

表5 英夫利昔单抗原研药与类似药的价格情况[17]

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