经口吸入制剂在治疗哮喘和COPD等呼吸系统疾病方面具有独特的优势,但是此类制剂药械合一,在创新和仿制方面均存在较高的壁垒,并且由于不同国家和地区的用药习惯,呈现不同的市场格局。2020年12月,国家药品审评中心发布了《经口吸入制剂仿制药生物等效性研究指导原则》,对吸入粉雾剂、吸入气雾剂和雾化吸入溶液的药学和临床研究提出了评价要求,使我国的吸入制剂进入发展的快车道。本文汇总了国外和国内吸入制剂市场和发展情况,分析了吸入制剂存在的技术壁垒,提出了我国吸入制剂未来发展的趋势和展望,以期为国内吸入制剂产业的发展提供参考。
<<Oral inhalation preparations have unique advantages in the treatment of respiratory diseases such as asthma and COPD. However,the integration of such preparations with equipment has high barriers to innovation and imitation,and due to the medication habits of different countries and regions,the market patterns are different. In December 2020,the National Center for Drug Evaluation issued the “Guiding Principles for the Research on the Bioequivalence of Generic Drugs of Oral Inhalation Preparations”,which proposed the pharmaceutical and clinical requirements on dry power inhalers,inhaled aerosols and inhalation solutions,enabling China’s inhalation preparations to develop rapidly. This paper reviews the development of foreign and domestic inhalation preparation markets,analyzes the technical barriers existing in inhalation preparations,and predicts the future development trend and prospect of inhalation preparations in China,with a view to providing references for the development of domestic inhalation industry.
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