Contribution of animal studies to evaluate the similarity of biosimilars to refrence products

van Meer Peter J. K.; Ebbers Hans C.; Kooijman Marlous; Gispen-de Wied Christine C.; Silva-Lima Beatriz; Moors Ellen H. M.; Schellekens Huub

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Contribution of animal studies to evaluate the similarity of biosimilars to refrence products

机译：动物研究贡献评估生物仿制性的相似性参考产品

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The European Union (EU) was the first region to establish a regulatory framework for biosimilars, in which animal studies are required to confirm similarity to a reference product. However, animal studies described in European public assessment reports (EPARs) or marketing authorization applications (MAAs) did not identify clinically or toxicologically relevant differences despite differences in quality, suggesting that animal studies lack the sensitivity to confirm biosimilarity. Scientific advice provided learning opportunities to evolve existing guidance. Altogether, the data support a step-wise approach to develop biosimilars that focuses on quality and clinical efficacy of biosimilar. This approach might be more effective and does not necessarily require animal studies, which is also reflected in new EU draft guidance.

机译：欧洲联盟（欧盟）是建立生物仿制性监管框架的第一个区域，其中需要动物研究确认与参考产品的相似性。然而，欧洲公共评估报告（盛宝膜）或营销授权申请（MAA）中描述的动物研究在临床或毒理学上差异尽管质量差异，但表明动物研究缺乏确认生物脂序的敏感性。科学建议提供了发展现有指导的学习机会。完全，数据支持一种迈喻的方法来开发侧重于生物素质的质量和临床疗效的生物纤维单模。这种方法可能更有效，并不一定需要动物研究，这也反映在新的欧盟指导草案中。

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来源
《Drug discovery today》 |2015年第4期|共8页
作者
van Meer Peter J. K.; Ebbers Hans C.; Kooijman Marlous; Gispen-de Wied Christine C.; Silva-Lima Beatriz; Moors Ellen H. M.; Schellekens Huub;
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作者单位

Univ Utrecht Utrecht Inst Pharmaceut Sci Dept Pharmaceut NL-3584 CG Utrecht Netherlands;

Univ Utrecht Utrecht Inst Pharmaceut Sci Dept Pharmaceut NL-3584 CG Utrecht Netherlands;

Univ Utrecht Copernicus Inst Sustainable Dev Innovat Studies NL-3584 CS Utrecht Netherlands;

Med Evaluat Board NL-3531 AH Utrecht Netherlands;

Univ Lisbon iMED UL Dept Pharmacol Sci P-1649003 Lisbon Portugal;

Univ Utrecht Copernicus Inst Sustainable Dev Innovat Studies NL-3584 CS Utrecht Netherlands;

Univ Utrecht Utrecht Inst Pharmaceut Sci Dept Pharmaceut NL-3584 CG Utrecht Netherlands;

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正文语种 eng
中图分类药学;
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1. Contribution of animal studies to evaluate the similarity of biosimilars to refrence products [J] . van Meer Peter J. K., Ebbers Hans C., Kooijman Marlous, Drug discovery today . 2015,第4期

机译：动物研究以评估生物仿制药与参考产品的相似性
2. Contribution of animal studies to evaluate the similarity of biosimilars to refrence products [J] . van Meer Peter J. K., Ebbers Hans C., Kooijman Marlous, Drug discovery today . 2015,第4期

机译：动物研究贡献评估生物仿制性的相似性参考产品
3. Contribution of animal studies to evaluate the similarity of biosimilars to reference products [J] . Peter J.K. van Meer, Hans C. Ebbers, Marlous Kooijman, Drug discovery today . 2015,第2期

机译：动物研究贡献评估生物仿制性的相似性参考产品
4. HOS Biosimilarity and Comparability - Objective, Quantifiable HOS Comparisons: A Biosimilar Case Study Utilizing Circular Dichroism [C] . Darek Sliwa Protein Engineering Summit. . 2018

机译：HOS BioSimilliantity和可比性 - 目标，可量化的HOS比较：利用圆形二分的生物仿例研究
5. ANTIBIOTIC RESIDUES IN ANIMAL PRODUCTS. CONTRIBUTION OF METABOLIC STUDIES TO THE EVALUATION OF TOXICOLOGICAL RISKS FOR HUMAN CONSUMERS. (FRENCH TEXT) (PROTEIN BINDING, ALLERGY, HEMATOTOXICITY). [D] . WAL, JEAN-MICHEL. 1985

机译：动物产品中的抗生素残留。代谢研究对人类消费者毒理风险评估的贡献。（法语文本）（蛋白质结合，过敏，血液中毒）。
6. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy [O] . Kalpna Desai, Priya Misra, Sanyukta Kher, 2018

机译：临床证实证明生物仿制药吡格非司亭具有相似性：一项针对拟进行的生物仿制药吡格非司亭与美国许可和欧盟批准的参考药物在接受骨髓抑制化学疗法的乳腺癌患者中进行的三项随机等效研究
7. Contribution of animal studies to evaluate the similarity of biosimilars to reference products [O] . Peter J.K. van Meer, Hans C. Ebbers, Marlous Kooijman, 2015

机译：动物研究贡献评估生物仿制性的相似性参考产品
8. Guidance for Industry No. 207: Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals. Marker Residue Depletion Studies to Establish Product Withdrawal Periods. VICH GL48(R). [R] . 2015

机译：第207号工业指南：评估食用动物中兽药代谢和残留动力学的研究。建立产品退出期的标记残留消耗研究。 VICH GL48（R）。

Contribution of animal studies to evaluate the similarity of biosimilars to refrence products

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