化学仿制药参比制剂遴选申请平台申请情况分析及参比制剂选择的几点考虑

Analysis and consideration on the applications of the reference preparation platform for the chemical generic drugs

为有序推进仿制药一致性评价提供科学依据与参考。通过近2年来化学仿制药参比制剂遴选申请平台数据,从具体品种、剂型、备案机构和适应证等多个维度,分析化学仿制药参比制剂遴选申请平台备案信息情况及其主要特征。化学仿制药参比制剂遴选申请平台提出申请的品种均具有较大市场规模,自2019年1月起呈现逐月显著上升的态势,参比制剂申请机构主要集中在东南部沿海省份,备案剂型中注射剂超过50%,备案较为集中的品种适应证以抗感染、消化系统药物占比最高。参比制剂为化学仿制药研发过程中关键因素之一,建议研发机构在充分调研的前提下及时提出备案申请。

To provide scientific evidence and reference for generic drug consistency evaluation.According to the records on the reference preparation filing platform for the consistency evaluation of generic drugs in recent 2 years,from multiple dimensions such as variety,dosage form,applicant agency,indicationand market size,analyzed the characteristics of the reference preparation application and choice in China.From January 2019,the records of reference preparation application have been rapidly increased monthly.Indications of most drugs were anti-infective and digestive system drugs,and more than 50%of records were injection.The application of reference preparation in China has obvious regional characteristics.The choice of reference preparation was a key point in the generic drugs research process,and it is suggested that R&D institutes should timely submit the applications for filing on the basis of full investigation.