Whereas generic drugs offer a cost‐effective alternative to brand name drugs, regulators need a method to assess therapeutic equivalence in a post‐market setting. We develop such a method in the context of assessing the therapeutic equivalence of immediate release venlafaxine, based on a large insurance claims data set provided by OptumLabs^\circledR. To address this question properly, our methodology must deal with issues of non‐adherence, secular trends in health outcomes and lack of treatment overlap due to sharp uptake of the generic drug once it becomes available. We define, identify (under assumptions) and estimate (using G‐computation) a causal effect for a time‐to‐event outcome by extending regression discontinuity to survival curves. We do not find evidence for a lack of therapeutic equivalence of brand and generic immediate release venlafaxine.

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品牌与一般：解决不遵守，长期趋势和不重叠的问题

仿制药可提供一种经济有效的替代名牌药物的替代方法，而监管机构则需要一种方法来评估上市后环境中的治疗等效性。我们根据OptumLabs ^{\ circledR}提供的大量保险索赔数据集，在评估速释文拉法辛的治疗等效性的背景下开发了这种方法。为了适当地解决这个问题，我们的方法必须解决不依从性，健康结果的长期趋势以及因通用药物一经获得就迅速吸收引起的治疗缺乏重叠的问题。我们定义，识别（根据假设）和估算（使用G计算）通过将回归不连续性扩展到生存曲线，从而对事件最终结果产生因果关系。我们找不到证据表明缺乏品牌和通用即释文拉法辛的治疗等效性。