仿制药与品牌药的疗效博弈

Comparative Clinical Trials for Generic Drugs and Brand Drugs Setting off

仿制药的疗效最近在临床上遭到质疑,梯瓦制药公司因此发起了一项比较抗抑郁药安非他酮的仿制药与品牌药疗效的临床试验。仅靠生物等效性试验或许已经不能完全满足仿制药的审批。

Since the eff icacy of generic drugs has been questioned recently in clinical use,Teva Pharmaceuticals has launched a comparable clinical trial for the efficacy of generic and brand antidepressant bupropion. Bioequivalence testing alone may not fully satisfy the requirement for generic drug approval.