注射用阿扎胞苷仿制药豁免体内生物等效性研究的一般考虑

General considerations on bio-waiver using quality assessment of azacitidine injection

注射用阿扎胞苷是FDA批准的第一个用于骨髓增生异常综合征(myelodysplastic syndromes,MDS)的药物,可提高高危MDS患者生存质量,显著延长其总生存期(OS)与向急性髓细胞白血病(AML)转化的时间。注射用阿扎胞苷复溶后的给药形式之一为皮下注射的混悬液。基于本品的特殊性,本文探讨了采用体外药学评价的方法来豁免体内生物等效性研究的可能性,有利于加快仿制药的研发,促进临床用药可及性。

Azacitidine injection is the first medication that was approved by FDA for myelodysplastic syndromes(MDS),which can improve the quality of life of high-risk MDS patients,prolong their overall survival(OS) and transformation time to acute myeloid leukemia(AML).The reconstituted suspension was administrated through subcutaneous injection.According to the characteristics of the product,this paper discusses general considerations on using bio-waiver to replace quality assessment method,which benefits the development of generic drug and promotes the accessibility of drug.