国内专利后原研药及其仿制药的现状研究

Research of Present Domestic Situation on Off-patent Originals and Generics

目的:为了了解国内专利后原研药及其仿制药的总体情况,为仿制药质量一致性评价及相关政策研究提供依据。方法:通过对上海医院购药信息系统(Shanghai Purchasing Drug Information System,HPDIS)中2002—2011年的数据整理和分析,对专利后原研药及其仿制药的数量、剂型分布和比价进行研究。结果:目前市场上专利后原研药或仿制药的通用名有300个。在仿制药中片剂和胶囊剂占了约50%,注射剂占了约33%,其他剂型则较少。总体上,相同年份、相同通用名、相同剂型的仿制药的价格是其专利后原研药价格的60%左右,但也有一些差价悬殊和价格倒挂的品种。结论:仿制药质量一致性评价会对药品质量、制药行业、药品定价和药品费用等产生较大的影响,有关各方应该尽早预判并作相应准备。

Objective： In order to understand the general situation of off-patent originals and generics in the domestic market, evidences for quality consistency evaluation for generics and related policies were provided. Methods： Through data reduction and analysis of Shanghai Purchasing Drug Information System （HPDIS）, quantity, dosage form distribution and price ratios of generics and their off-patent originals were researched. Results： There are 300 generic names of off-patent originals in the domestic market. Half dosage forms of generics are tablets and capsules, 33% are injections, and the rest own a smaller proportion. The overall price ratio of generics and their off-patent originals in the same year and the same dosage form is about 60%, but there are also some great disparities and price inversions between generics and their off-patent originals. Conclusion： Quality consistency evaluation for generics will have a strong impact on quality, industry, pricing and expenditure of pharmaceuticals, parties concerned should predict and prepare for it.