Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
复制标题
生物仿制药和参考生物治疗药物之间生物分析相似性的系统验证：委员会关于开发和验证单一配体结合测定以支持药代动力学评估的建议
DOI：
10.1208/s12248-014-9669-5
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发表时间：
2014
期刊：
影响因子：
4.5
通讯作者：
R. Bowsher
中科院分区：
文献类型：
--
作者：
J. Marini;M. Anderson;Xiao;John Chappell;Todd Coffey;D. Gouty;Aparna Kasinath;Vera Koppenburg;P. Oldfield;Shannon Rebarchak;R. Bowsher
对于生物类似药开发，证明生物类似药与参比制剂具有相似的理化特性、疗效和安全性至关重要。因此，能够证明生物相似性的药代动力学（PK）和免疫原性（抗药抗体，ADA）试验至关重要。在美国药学科学家协会（AAPS）配体结合试验生物分析焦点小组（LBABFG）的主持下，生物仿制药行动计划委员会（APC）于2011年成立。本生物类似药APC的目标是提供一个论坛，以深入讨论支持生物类似药开发的PK和免疫原性试验开发和验证相关问题，并提出相关建议。生物类似药APC关于开发和验证配体结合试验（LBA）以支持生物类似药开发的PK评估的建议如下。用于支持免疫原性评估的LBA开发和验证的分析建议将作为单独白色文件的主题。
For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Under the auspices of the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), a Biosimilars Action Program Committee (APC) was formed in 2011. The goals of this Biosimilars APC were to provide a forum for in-depth discussions on issues surrounding the development and validation of PK and immunogenicity assays in support of biosimilar drug development and to make recommendations thereof. The Biosimilars APC’s recommendations for the development and validation of ligand-binding assays (LBAs) to support the PK assessments for biosimilar drug development are presented here. Analytical recommendations for the development and validation of LBAs to support immunogenicity assessments will be the subject of a separate white paper.