Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
复制标题
用于生物仿制药开发和批准的药效生物标志物：研讨会摘要。
DOI：
10.1002/cpt.2795
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发表时间：
2023
影响因子：
6.7
通讯作者：
Strauss,DavidG
中科院分区：
文献类型：
--
作者：
Florian,Jeffry;Sun,Qin;Schrieber,SarahJ;White,Richard;Shubow,Sophie;Johnson-Williams,BernadetteE;Sheikhy,Morasa;Harrison,NicholasR;Parker,ValerieJ;Wang,Yow-Ming;Strauss,DavidG
美国食品和药物管理局 (FDA) 生物仿制药指南描述了如何根据临床药代动力学和药效 (PD) 生物标志物数据批准生物仿制药，而无需进行疗效终点的比较临床研究。然而，在过去十年中，这种类型的临床开发计划仅针对少数 FDA 批准的生物仿制药产品实施。为了鼓励在生物仿制药开发和审批中使用 PD 生物标志物，杜克-马戈利斯健康政策中心与 FDA 合作，于 2021 年 9 月 20 日至 21 日举办了为期两天的虚拟公共研讨会，题为“生物仿制药开发和审批的药效生物标志物”。该公共研讨会是全球监管机构、生物制药开发商和学术研究人员的论坛，讨论 PD 生物标志物在提高仿制药效率方面当前和未来的作用。生物仿制药的开发和批准。研讨会的目标包括：(i) 讨论利用 PD 生物标志物进行生物仿制药开发和批准的当前和潜在的未来状态； (ii) 总结 FDA 推动生物仿制药开发的举措； (iii) 描述利益相关者在生物仿制药开发中使用 PD 生物标志物的经验； (iv) 解释促进 PD 生物标志物在生物仿制药开发中更广泛应用的研究工作。本文件总结了 2021 年 9 月为期两天的公共研讨会每场会议的演讲和小组讨论，内容涉及 PD 生物标志物在生物仿制药开发中的应用。
The US Food and Drug Administration (FDA) Biosimilars Guidance describes how biosimilars may be approved based on clinical pharmacokinetic and pharmacodynamic (PD) biomarker data, without comparative clinical studies with efficacy end points. This type of clinical development program, however, has only been implemented for a small number of FDA‐approved biosimilar products over the last decade. To encourage the use of PD biomarkers in biosimilar development and approval, the Duke‐Margolis Center for Health Policy collaborated with the FDA to host a two‐day virtual public workshop entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” on September 20–21, 2021. The public workshop was a forum for global regulators, biopharmaceutical developers, and academic researchers to discuss the current and future role of PD biomarkers in improving the efficiency of biosimilar development and approval. The workshop objectives included: (i) discuss the current and potential future state of leveraging PD biomarkers for biosimilar development and approval; (ii) summarize the FDA's initiatives to advance biosimilar development; (iii) describe stakeholders' experience with PD biomarkers in biosimilar development; and (iv) explain research efforts to promote broader application of PD biomarkers in biosimilar development. This document summarizes presentations and panel discussions from each session of the two‐day September 2021 public workshop covering the application of PD biomarkers for biosimilar development.