1. Increase the reliance on analytical data in a demonstration of biosimilarity
目标1：在生物类似药相似性论证中加强对分析数据的依赖
1.1 Research Priority A: Characterize relationships between product quality attributes (physiochemical or biological) with clinical performance
研究重点A：表征产品质量属性（物理化学或生物学）与临床表现之间的关系
Landscape Assessment of Biosimilar Submissions
生物类似药申报现状评估
1.2 Research Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes
研究重点B：探索分析技术的现代化如何更好和/或更有效地检测相关质量属性
Establishment of A Feasible Method to Quantify Major Glycoforms of Human IgG1 mAb Drugs and Their Biosimilars in Culture Media as a Component of Process Analytic Technology
构建适用于过程分析技术（PAT）的人IgG1单抗药物及其生物类似药培养基中主要糖型定量检测可行方法
OnePotGlycan - A Chemoenzymatic Method for Simultaneous Profiling of N and O-glycans in One-Pot
Onepotglycan -一种一锅法同时分析N -和O -聚糖的化学酶法
Assessment of the Performance of MAM vs Conventional QC Methods for Evaluation of Product Quality Attributes of Adalimumab and Etanercept
Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals
缩小差距：利用国外真实世界数据支持可互换的生物类似药审批
2.2 Research Priority E: Define approaches that will increase feasibility of biosimilar development (e.g., PD biomarkers, MIDD including artificial intelligence and/or machine learning )
Critical Factors for Standardization and Accuracy of PK Assays of PEGylated Biosimilars
聚乙二醇化生物类似药PK测定的标准化和准确性的关键因素
Evidence-Based Approach to the Design of Clinical Pharmacology Studies
临床药理学研究设计的循证方法
2.3 Research Priority F: Identify user interface differences that will likely lead to differences in use error rates or use success rates in the context of pharmacy substitution
，并于2024年1月完成了对