2003–2020年中国仿制药上市和新药市场独占期研究

Generic development and market exclusivity period in China:an analysis from 2003 to 2020

中国近期提出给予新药、孤儿药和儿科药物6年的数据保护期,以鼓励相关药物的研发创新。本研究评估了2003至2020年在中国批准上市的356种新小分子药物的仿制药上市情况和市场独占期。所有新药中,155个(43.5%)新药有仿制药上市,市场独占期中位数为5.6(四分位数:2.4–9.4)年。进口药物、口服缓释药物和神经系统药物比其它药物的仿制药上市比例更高(P<0.001,P=0.039,P<0.001)。国产药品的市场独占期中位数比进口药品更长(8.4 vs 5.7年)。市场独占期中位数从抗肿瘤和免疫调节剂的3.6年到消化道和代谢药物的6.8年不等。如果获得6年的数据保护期,新药的市场独占期中位数预计将增加一倍。较长的市场独占期可能降低患者药品可及性,政府在制定相关政策时应考虑在鼓励创新和确保药品可及性间寻求平衡。

China recently proposed a 6-year regulatory exclusivity period to incentivize research and development in new drugs,orphan drugs,and pediatric drugs.Our study assessed the generic entry status and the duration of market exclusivity for 356 new small-molecule drugs approved in China from 2003 to 2020.Of these,155 drugs(43.5%)experienced generic entry,with a median market exclusivity period of 5.6 years(interquartile range:2.4–9.4).Imported drugs,oral common-release agents,and drugs for the nervous system were more prone to generic entry(P<0.001,P=0.039,and P<0.001,respectively).Domestic new drugs had a longer median market exclusivity(8.4 years)compared to imported drugs(5.7 years).Market exclusivity varied from 3.6 years for antineoplastic and immunomodulating agents to 6.8 years for drugs for the alimentary tract and metabolism.If the proposed 6-year regulatory exclusivity is implemented,the market exclusivity duration for new drugs is anticipated to double.It is essential for the government to carefully weigh the impact of such policies on balancing innovation incentives and ensuring drug affordability.