我国生物类似药发展现状及挑战

Development Status and Challenges of Biosimilars in China

目的:促进生物类似药发展,提高临床用药安全性和经济性。方法:通过文献分析法,了解我国生物类似药的发展现状,并对其生产研发、临床应用和安全监测方面存在的问题进行分析,参考霍尔三维空间结构模型,构建生物类似药管理结构。结果:我国生物类似药发展过程面临本土培养基供应受限、质量相似性难控、医患双方接受度不高、临床循证指南缺失等挑战。结论:分阶段关注生物类似药的发展,前端生产研发中,促进本土培养基企业培育,规范制药企业生产;中端临床应用中,完善临床循证指南,加强医务人员专业教育;末端安全监测中,加强不良反应监测以及对特殊人群的重点监测。

Objective To promote the development of biosimilars,and to improve the safety and economy of clinical medication.Methods Through literature analysis,the development status of biosimilars in China was understood,and the problems existing in production and development,clinical application and safety monitoring were analyzed.Referring to the Hall three dimensions structure model,the management structure of biosimilars was constructed.Results In the development process of biosimilars in China,it faced the challenges such as limited local supply of biosimilar culture media,difficult control of quality similarity,low acceptance by both doctors and patients,and lack of clinical evidence-based guidelines.Conclusion Greater attention should be paid to the three stages of time dimension in the spatial structure of biosimilars.It is necessary to promote the cultivation of local culture medium enterprises and standardize the production of pharmaceutical enterprises in the front-end production,research and development,improve the clinical evidence-based guidelines and strengthen the professional education of medical staff in the middle-end clinical application,and strengthen the monitoring of adverse reactions and the key monitoring of special populations in the end-end safety detection.