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低分子肝素(low-molecular-weight heparin,LMWH)广泛用于临床预防和治疗血栓栓塞性疾病。我国已有多个低分子肝素仿制品获准上市。对此类产品,我国药品监管机构制定了严格的药学标准,但还没有制定临床方面的评价规范。而近年,欧美药品监管机构对低分子肝素仿制产品的技术要求趋于清晰,发布相关指导性文件,以确保仿制品与被仿制产品的一致性。本文回顾了国内外的监管实践和技术评价进展,对低分子量肝素类注射剂临床研究的必要性和可行性进行了讨论。对低分子量肝素类注射剂仿制品,在药学和非临床研究的基础上,通过验证性或桥接性临床试验,以确保临床安全性和疗效,具有重要的意义。
Low-molecular-weight heparin (LMWH) is widely used in clinical prevention and treatment of thromboembolic diseases. China has more than one low-molecular-weight heparin generic was approved. For such products, China’s drug regulatory agencies have formulated strict pharmaceutical standards, but no clinical evaluation norms. In recent years, Europe and the United States drug regulatory agencies on the technical requirements of low molecular weight heparin generic products tend to be clear, release relevant guidance documents to ensure that imitation and imitation of the product is consistent. This review reviews the progress of regulatory practice and technology evaluation at home and abroad and discusses the necessity and feasibility of clinical studies on low molecular weight heparin injections. The low molecular weight heparin injection imitation, based on the pharmacy and non-clinical research, through the confirmatory or bridging clinical trials to ensure clinical safety and efficacy, of great significance.