July 18, 2018
Authored and Edited by Bonnie Fletcher Price, Ph.D.; Linda A. Wadler
2018年6月21日美国食品与药品管理局(FDA)撤销了其在2017年9月发布的行业指南草案《分析相似性评估的统计方法》。该指南草案旨在为开发仿制药产品的主体就如何评估生物仿制药和参照药的分析相似性提供建议。针对该草案,公众提出的一系列可能影响生物仿制药研发的成本和效率的问题,考虑了公众意见后,FDA决定将进一步考量所涉及的科学和法规问题,并且撤销该指南草案。
FDA表示其计划发布新的指南草案,该草案将在分析数据的评估中体现目前最先进的技术,并且提出“合适的方法来分析数据,以说明参照药产品中潜在的批次间的差异性”,以及“注重为仿制药开发者提供适当的灵活性…来激励生物仿制药的高效研发,而不降低FDA评估生物仿制药市场准入的严格科学标准”
建议读者点击此处回顾FDA的撤销全文。
Food and Drug Administration (FDA), FDA Guidance, Biologic License Application (BLA), abbreviated biologic license application (aBLA), Biologics Price Competition and Innovation Act (BPCIA)
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