Chazin Howard D, Peters John R, Catterson Debra M, Osterhout James L, Forsyth Linda M, Lee Jung E, Kim Edward K, Feibus Karen B
1 U.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2019 Mar;53(2):249-253. doi: 10.1177/2168479018774557. Epub 2018 May 9.
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug. These analyses allow FDA to determine that the generic drug will perform in the patient in the same way, with the same safety and efficacy profiles, as the brand name drug. Allowable differences and the precise definition of what is meant by equivalence are critical to maintaining the quality, efficacy, and safety of generic drugs. The FDA Office of Generic Drugs' (OGD's) Clinical Safety Surveillance Staff (CSSS) has developed investigative processes that complement the broader FDA safety efforts that focus on the potential impact of allowable differences and equivalence determinations for generic drugs. Two recent examples of the CSSS's processes include a clonidine transdermal system and lansoprazole oral disintegrating tablet. Ongoing efforts of the CSSS result in improvements to the FDA's review processes and the quality of generic drugs in the US market.
美国食品药品监督管理局（FDA）的仿制药计划极大地提高了价格合理、质量上乘的仿制药的可及性。仿制药获批的基础是药物等效性和生物等效性的两级监管框架。这两者的内在要求是，基于仿制药与品牌药之间不存在显著差异的确凿证据，考虑剂型和生物等效性数据的临床相关性，以支持治疗等效性的推断。这些分析使FDA能够确定仿制药在患者体内的表现与品牌药相同，具有相同的安全性和疗效。允许的差异以及等效性的确切定义对于维持仿制药的质量、疗效和安全性至关重要。FDA仿制药办公室（OGD）的临床安全监测人员（CSSS）已制定调查程序，以补充FDA更广泛的安全工作，这些工作侧重于仿制药允许差异和等效性判定的潜在影响。CSSS程序的两个近期例子包括可乐定透皮系统和兰索拉唑口腔崩解片。CSSS的持续努力改进了FDA的审评程序以及美国市场上仿制药的质量。
