Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS Biologicals Pub Date : 2023-02-01 DOI:10.1016/j.biologicals.2023.101666

Anna N. Arefeva , Igor E. Makarenko , Valeria B. Saparova , Dzhina D. Karal-ogli , Alina N. Afanaseva , Artem R. Dorotenko , Anna V. Kalatanova , Denis V. Kurkin , Alexandr L. Khokhlov , Roman V. Drai

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引用次数: 1

Abstract

The results of preclinical studies of romiplostim analogue GP40141 are presented.

The effect of a cell proliferation, phosphorylation of the TPO receptor and JAK2 phosphorylation were studied in the presence of romiplostim and in the presence of GP40141 in a cell line of mice (Mus musculus) lymphoblasts with stable expression of human TPO receptor 32D-hTPOR clone 63. Binding to the TPO receptor and to the neonatal Fc receptor (FcRn) was examined for both romiplostim and the developed analogue.

In Sprague-Dawley rats, the dynamics of platelet count after the administration of romiplostim or GP40141 were determined. The pharmacokinetics of romiplostim and GP40141, as well as the dynamics of platelet count, were studied in cynomolgus monkeys. The serum concentrations of romiplostim were determined using a modified colorimetric enzyme-linked immunosorbent assay (ELISA).

The data obtained allow us to assert the similarity of the biological action of Nplate® and GP40141.

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生物类似药romiplostim与原药的可比性:蛋白质特性、动物药效学和药代动力学

介绍了romipostim类似物GP40141的临床前研究结果。在具有人TPO受体32D-hTPOR克隆63稳定表达的小鼠（Mus musculus）淋巴母细胞细胞系中，在romipostim存在和GP40141存在下，研究了细胞增殖、TPO受体磷酸化和JAK2磷酸化的影响。对romipostim和开发的类似物与TPO受体和新生儿Fc受体（FcRn）的结合进行了检测。在Sprague-Dawley大鼠中，测定给药romipostim或GP40141后的血小板计数动态。研究了romipostim和GP40141在食蟹猴体内的药代动力学以及血小板计数的动力学。使用改良的比色酶联免疫吸附试验（ELISA）测定romipostim的血清浓度。获得的数据使我们能够断言Nplate®和GP40141的生物作用的相似性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

期刊介绍： Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.