Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.
Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.
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与使用特定产品的治疗等效性确定批准的仿制药相关的转换。
DOI：
10.1002/pds.4009
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发表时间：
2016
影响因子：
2.6
通讯作者：
Kesselheim,AaronS
中科院分区：
文献类型：
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作者：
Gagne,JoshuaJ;Polinski,JenniferM;Jiang,Wenlei;Dutcher,SarahK;Xie,Jing;Lii,Joyce;Fulchino,LisaA;Kesselheim,AaronS
美国食品和药物管理局对仿制药的批准依赖于证明药物等效性和生物等效性;然而，一些药品具有独特的属性，需要特定的产品批准途径。我们评估了患者从通过这种approaches.MethodsWe批准的四种药物的通用版本切换回品牌版本的比率，我们使用Optum LifeSciences Research Database的数据来识别使用研究药物（阿卡波糖片，鲑鱼降钙素鼻喷雾剂，依诺肝素钠注射液和文拉法辛缓释片）或对照药物的品牌版本的患者。我们对患者进行了跟踪，以确定他们是否改用仿制药版本，然后对改用仿制药版本的患者进行了跟踪，以确定他们是否改用品牌版本。我们计算了转换和转换回率，并使用Kaplan-Meier和对数秩检验来比较研究和对照药物之间的比率。研究药物从品牌转换为仿制药的转换率范围为66 - 106例/100人年，对照药物为80 - 110例/100人年。研究药物转换回品牌版本的发生率范围为5 - 37，对照药物为3 - 53。文拉法辛的转回率高于舍曲林（p< 0.01），降钙素高于阿仑膦酸钠（p= 0.01）。文拉法辛与帕罗西汀（p< 0.01）和阿卡波糖与那格列奈（p< 0.01）的转换率较低。阿卡波糖与格列美脲（p= 0.97）和依诺肝素与磺地肝素（p= 0.11）的发生率相似。结论与对照药物相比，患者不太可能系统性地从四种研究药物的仿制药转换回品牌版本。版权所有© 2016约翰威利父子有限公司.
PurposeUS Food and Drug Administration approval for generic drugs relies on demonstrating pharmaceutical equivalence and bioequivalence; however, some drug products have unique attributes that necessitate product‐specific approval pathways. We evaluated rates of patients' switching back to brand‐name versions from generic versions of four drugs approved via such approaches.MethodsWe used data from Optum LifeSciences Research Database to identify patients using a brand‐name version of a study drug (acarbose tablets, salmon calcitonin nasal spray, enoxaparin sodium injection, and venlafaxine extended release tablets) or a control drug. We followed patients to identify switching to generic versions and then followed those who switched to identify whether they switched back to brand‐name versions. We calculated switch and switch‐back rates and used Kaplan–Meier and log‐rank tests to compare rates between study and control drugs.ResultsOur cohort included 201 959 eligible patients. Brand‐to‐generic switch rates ranged from 66 to 106 switches per 100 person‐years for study drugs and 80 to 110 for control drugs. Rates of switch‐back to brand‐name versions ranged from 5 to 37 among study drugs and 3 to 53 among control drugs. Switch‐back rates were higher for venlafaxine vs. sertraline (p< 0.01) and calcitonin vs. alendronate (p= 0.01). Switch‐back rates were lower for venlafaxine vs. paroxetine (p< 0.01) and acarbose vs. nateglinide (p< 0.01). Rates were similar for acarbose vs. glimepiride (p= 0.97) and for enoxaparin vs. fondiparinux (p= 0.11).ConclusionAs compared to control drugs, patients were not more likely to systematically switch back from generic to brand‐name versions of the four study drugs. Copyright © 2016 John Wiley & Sons, Ltd.