The diverse nature of complex drug products poses challenges for the development of regulatory guidelines for generic versions. While complexity is not new in medicines, the technical capacity to measure and analyze data has increased. This requires a determination of which measurements and studies are relevant to demonstrate therapeutic equivalence. This paper describes the views of the NBCD Working Group and provides pragmatic solutions for approving complex generics by making best use of existing U.S. Food and Drug Administration's abbreviated approval pathways 505(j) and 505(b)(2). We argue that decisions on the appropriateness of submitting a 505(j) or 505(b)(2) application can build on the FDA's complex drug product classification as well as the FDA's much applauded guidance document for determining whether to submit an ANDA or a 505(b)(2) application. We hope that this paper contributes to the discussions to increase the clarity of regulatory approaches for complex generics, as well as the predictability for complex generic drug developers, to facilitate access to much-needed complex generics and to promote the sustainability of the healthcare system.

中文翻译：

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通过美国 FDA 505(j) 或 505(b)(2) 批准途径针对复杂仿制药的务实监管方法

复杂药品的多样性给仿制药监管指南的制定带来了挑战。虽然药物的复杂性并不新鲜，但测量和分析数据的技术能力已经提高。这需要确定哪些测量和研究与证明治疗等效性相关。本文描述了 NBCD 工作组的观点，并通过充分利用现有美国食品和药物管理局的简化批准途径 505(j) 和 505(b)(2) 为批准复杂仿制药提供务实的解决方案。我们认为，关于提交 505(j) 或 505(b)(2) 申请的适当性的决定可以建立在 FDA 的复杂药品分类以及 FDA 的“ 非常受欢迎的指导文件，用于确定是提交 ANDA 还是 505(b)(2) 申请。我们希望本文有助于讨论提高复杂仿制药监管方法的清晰度，以及复杂仿制药开发商的可预测性，以促进获得急需的复杂仿制药并促进医疗保健系统的可持续性。