Biosimilar monoclonal antibodies: the scientific basis for extrapolation

Schellekens Huub; Lietzan Erika; Faccin Freddy; Venema Jaap

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Biosimilar monoclonal antibodies: the scientific basis for extrapolation

机译：生物仿制药单克隆抗体：外推的科学依据

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Introduction: Biosimilars are biologic products that receive authorization based on an abbreviated regulatory application containing comparative quality and nonclinical and clinical data that demonstrate similarity to a licensed biologic product. Extrapolation of safety and efficacy has emerged as an important way to simplify biosimilar development. Regulatory authorities have generally reached the consensus that extrapolation of similarity from one indication to other approved indications of the reference product can be permitted if it is scientifically justified.

机译：简介：生物仿制药是根据简短的监管申请获得授权的生物制品，其中包含比较质量以及证明与许可的生物制品具有相似性的非临床和临床数据。安全性和有效性的推断已成为简化生物仿制药开发的重要方法。监管机构通常已达成共识，即如果科学证明合理，则可以允许从一种适应症外推至参考产品的其他批准适应症。

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《Expert opinion on biological therapy》 |2015年第11期|共14页
作者
Schellekens Huub; Lietzan Erika; Faccin Freddy; Venema Jaap;
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原文格式 PDF
正文语种 eng
中图分类治疗学;
关键词
biosimilars; extrapolation; infliximab; monoclonal antibodies; TNF inhibitors;

机译：生物仿制药;外推;英夫昔单抗;单克隆抗体;TNF抑制剂;

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1. Biosimilar monoclonal antibodies: the scientific basis for extrapolation [J] . Schellekens Huub, Lietzan Erika, Faccin Freddy, Expert opinion on biological therapy . 2015,第11期

机译：生物仿制药单克隆抗体：外推的科学依据
2. Biosimilar Monoclonal Antibodies: A Canadian Regulatory Perspective on the Assessment of Clinically Relevant Differences and Indication Extrapolation [J] . Scott Bradley J., Klein Agnes V., Wang Jian The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2015,第Suppla3期

机译：生物仿制药单克隆抗体：关于临床相关差异和适应症外推评估的加拿大监管观点
3. Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval [J] . Kudrin Alex, Knezevic Ivana, Joung Jeewon, Biologicals: Journal of the International Association of Biological Standardization . 2015,第1期

机译：生物仿制药单克隆抗体临床评估的案例研究：法规批准的科学考虑
4. Strategies to improve productivity of CHO-S cells expressing an anti-TNFa monoclonal antibody with biosimilar potential [C] . Ana Moro, Mateus luchese, Wagner Quintilio, Cell culture engineering conference . 2018

机译：提高表达具有生物类似潜力的抗TNFα单克隆抗体的CHO-S细胞生产力的策略
5. Cloning and expression of a biosimilar chimeric monoclonal antibody directed against the human epidermal growth factor receptor and its production in CHO cells for treatment of colo-rectal cancer. [D] . Motiwala, Hatim Maqbulhusen. 2012

机译：针对人表皮生长因子受体的生物仿制药嵌合单克隆抗体的克隆和表达及其在CHO细胞中的产生，用于治疗结肠直肠癌。
6. The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars [O] . Liese Barbier, Paul Declerck, Steven Simoens, 2019

机译：生物仿制药单克隆抗体在肿瘤学中的应用：曲妥珠单抗生物仿制药的临床研究
7. Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars [O] . Po-Chih Wu, Yi-Chen Yang, Der-Yuan Wang, 2018

机译：单克隆抗体生物纤维单模的科学和监管透视

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Biosimilar monoclonal antibodies: the scientific basis for extrapolation

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