Gallelli Luca, Palleria Caterina, De Vuono Antonio, Mumoli Laura, Vasapollo Piero, Piro Brunella, Russo Emilio
Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy and Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
Department of General Medicine, ASP Cosenza, Italy.
J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S110-4. doi: 10.4103/0976-500X.120972.
Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.
如果仿制药具有相同的活性成分、相同的剂型、相同的治疗适应症,并且与参比药品具有相似的生物等效性,那么它们就等同于品牌制剂。许多国家都提倡使用仿制药以降低药品价格。然而,在从品牌制剂转换为仿制药的过程中,关于临床疗效和安全性的一些问题,如生物等效性和辅料的作用,可能需要进一步阐明。总之,使用仿制药可能会导致疾病天数增加(复发时间)或治疗失败;另一方面,较高的药物浓度可能会使患者面临剂量依赖性副作用风险增加的问题。