Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes. As expedited development does not lessen the quality expectations, one challenge is providing adequate chemistry, manufacturing, and control (CMC) information required to support approval of a biological product. In particular, the analytical comparability and, in some cases, pharmacokinetic comparability studies needed to bridge the clinical material to the commercial material could delay submission of applications for life-saving medicines. While there is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Topic Q5E guidance on assessing comparability of biological products before and after manufacturing changes, specific guidance on the emerging issue of conducting comparability exercises in the face of expedited drug development is lacking. In July 2019, clinical pharmacologists and product quality chemists from the US FDA and industry representatives convened an FDA workshop for a scientific exchange about considerations and challenges around conducting comparability exercises for expedited programs for biological products. This article highlights discussions from the workshop.

由于临床开发时间紧迫，用于治疗严重疾病的生物制品的加速开发计划带来了挑战。由于加速开发不会降低质量期望，因此一项挑战是提供支持生物产品批准所需的足够的化学、制造和控制 (CMC) 信息。特别是，将临床材料与商业材料连接起来所需的分析可比性以及在某些情况下的药代动力学可比性研究可能会延迟提交救生药物的申请。虽然国际人用药品技术要求协调委员会 (ICH) 主题 Q5E 有关于评估制造变更前后生物制品可比性的指南，但针对在快速药物面前进行可比性练习的新问题的具体指南缺乏发展。2019 年 7 月，来自美国 FDA 的临床药理学家和产品质量化学家以及行业代表召集了 FDA 研讨会，就生物产品加速计划的可比性练习的考虑和挑战进行科学交流。本文重点介绍了研讨会的讨论。2019 年 7 月，来自美国 FDA 的临床药理学家和产品质量化学家以及行业代表召集了 FDA 研讨会，就生物产品加速计划的可比性练习的考虑和挑战进行科学交流。本文重点介绍了研讨会的讨论。2019 年 7 月，来自美国 FDA 的临床药理学家和产品质量化学家以及行业代表召集了 FDA 研讨会，就生物产品加速计划的可比性练习的考虑和挑战进行科学交流。本文重点介绍了研讨会的讨论。