国内药企对中国仿制药品的发展战略  

Generic Drug Development Strategy of Chinese Pharmaceutical Companies

作　　者：李霞 LI Xia

机构地区：[1]山东齐鲁制药集团有限公司药物研究院,山东济南250100

出　　处：《中国药物经济学》2018年第11期47-49,共3页China Journal of Pharmaceutical Economics

摘　　要：大力发展仿制药品是降低医疗支出、提高药品可及性、保障人民医疗健康水平的主要途径。以美国为代表的发达国家,建立了成熟的仿制药品研发、监管和流通替代体系,促进了仿制药品和创新药品的平衡发展。自2015年以来,我国大力改革药品监管政策、研发要求与国际接轨,推行上市药物一致性评价工作,使仿制药品的研发水平和质量得到提升。本文以齐鲁制药为例,简述国内药企在新政策环境下如何制定切实可行的研发战略,促使我国仿制药品研发取得显著成效。Development of generic drugs is the main measure of reducing healthcare expenses,improving drug availability,and protecting people's health.Developed countries such as America have gained balanced development of generics and innovative drugs through establishment of a series of policies about generic drug development, administration,marketing and substitution.Since 2015,China began to reform the system and policies of medicine regulation,become a member of ICH,push through quality consistency evaluation for marketed generics in order to improve the research and development level and assure the quality of drugs.This article,taking Qilu Pharmaceutical as an example,summarizes how local pharmaceutical companies make practical development strategy and achieve remarkable effect on development of generics in the new policy environment.

关 键 词：仿制药品 生物类似药 发展战略 齐鲁制药 

分 类 号：R95[医药卫生—药学] F426.72[经济管理—产业经济]