我国治疗性“生物仿制药”发展对策与思考

Strategies and thinking on similar biotherapeutic products(SBPs) in China

为保证我国患者能够用到安全、低价、有效并且质量可靠的生物技术药物产品,已有30余种"生物仿制药"在我国批准上市。在WHO的关于治疗性生物相似物指导原则出台以后,很多国家和地区的药品监管机构相继出台或正在积极制定专门针对"生物仿制药"的法规和技术指导原则。作为创新生物技术药物研发和"生物仿制药"产业大国,我国监管部门和生产企业应共同努力,积极思考和应对,尽快出台符合我国国情并总体符合WHO指导原则框架的"生物仿制药"指导原则,迎接机遇和挑战,使我国"生物仿制药"产业在新起点上实现再次飞跃。

In order to ensure most Chinese patients,particularly in the population with relatively low incomes,have access to the safe,low-cost,effective and quality-assured medicines,more than thirty of different non-innovator biological products have been marketed in China.After the WHO guidelines on evaluating similar biotherapeutic products（SBPs） had been published,many countries＇ and regions＇ regulatory agencies have finished or begin to actively engage in the development of bio-similar guidance and documents.As the major country of new biological product development and non-innovator biological product industry,the regulatory agency and manufacturers in China should collaborate to actively consider and response to it.It is an urgent demand for our country to promote the process of drafting the Chinese guidelines for SBPs considering both the local situation in China and the general WHO framework.This will help our country to face the opportunities and challenges,and may be of benefit for launching the industrial leap of non-innovator biological products again at the new level.