CAJ | 학술논문

　　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。
　　목적：위료료해국내전리후원연약급기방제약적총체정황，위방제약질량일치성평개급상관정책연구제공의거。방법：통과대상해의원구약신식계통（Shanghai Purchasing Drug Information System， HPDIS）중2002—2011년적수거정리화분석，대전리후원연약급기방제약적수량、제형분포화비개진행연구。결과：목전시장상전리후원연약혹방제약적통용명유300개。재방제약중편제화효낭제점료약50%，주사제점료약33%，기타제형칙교소。총체상，상동년빈、상동통용명、상동제형적방제약적개격시기전리후원연약개격적60%좌우，단야유일사차개현수화개격도괘적품충。결론：방제약질량일치성평개회대약품질량、제약행업、약품정개화약품비용등산생교대적영향，유관각방응해진조예판병작상응준비。
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.