仿制药质量与疗效一致性评价的生物豁免原则及各国及国际组织的生物等效性豁免品种

Principles of biowaiver about the consistency evaluation of generic drug products and varieties of biowaiver in countries and international organizations

目的为我国仿制药质量与疗效一致性评价的生物等效性试验,提供可豁免药物品种的参考。方法以《人体生物等效性试验豁免指导原则(征求意见稿)》为基础,以我国一致性评价的首批药物为前提,简要介绍和归纳美国食品药品管理局(FDA)、世界卫生组织(WHO)、欧洲药品局(EMA)的生物等效性试验豁免的标准和可申请豁免的药物品种。结果对比FDA,289个一致性评价药物品种中可申请豁免的有59个,不可申请豁免的有19个;对比WHO,可豁免的药物有10个,EMA中有1个。结论目前,我国生物等效性试验豁免的具体药物名单尚未公布,企业应该对比参考国内外的相关标准和具体药物,以加快一致性评价工作的进展。

Objective For bioequivalence test of the consistency evaluation of generic drug products, providing a reference of varieties of biowaiver. Methods Based on Human bioequivalence test waiver guidelines（draft）, on condition that first drug of the consistency evaluation, to introduce and conclude briefly the standards of biowaiver and varieties of biowaiver in FDA, WHO and EMA. Results Contrast to FDA, there are 59 varieties applied for the waiver and 19 varieties not applied for the waiver in the 289 varietie; compared to WHO, 10 drugs are exempted and 1 grug is exempted in EMA. Conclusion At present, the specific list of drugs are not published of biowaiver in our country, the pharmaceutical companies should compare and consult revelant standards and specific drugs in China and abroad, to speed up the progress of the consistency evaluation.