Safety study of romiplostim biosimilar

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Idiopathic thrombocytopenic purpura is a chronic autoimmune hematological disease caused by an increased destruction of platelets and associated thrombocytopenia, for the treatment of which the imported drug romiplostim is used. Сreation of the drug biosimilar provides a reduction in the cost of therapy and an access for the treatment to more patients.

The aim of the study was to compare the safety indicators of the reference drug and its biosimilar in vivo and in vitro.

Materials and methods. In the in vitro study, a model of “complement-dependent cytotoxicity” induced by the complement was formed on the 32D hTPOR clone 63-cell line, followed by a cell viability measurement with the CellTitter Glo® kit. An in vivo part of the study was carried out on Javanese macaque monkeys (Macaca fascicularis). During the experiment, the clinical condition, mortality, appetite of the animals, their body weight, body temperature, respiratory rate were assessed, the clinical parameters of blood and urine of the animals were also monitored, and the hemostasis indicators were additionally measured.

Results. In the in vitro experiment, the original drug romiplostim and its biosimilar GP40141 were compared in terms of EC50 values. The indicatirs did not show complement-dependent cytotoxicity. According to the in vivo results, no deviations were recorded in the clinical status of the animals and their feed intake, and no lethality was fixed out in the groups either. For all the parameters studied (body weight and temperature, respiratory rate, clinical urinalysis, clinical and biochemical blood tests, coagulation hemostasis), GP40141 and romiplostim, when administered at the doses equivalent to 10 toxic doses (TDs), had comparable effects.

Conclusion. In the comparison of safety performance both in vitro and in vivo, the original drug romiplostim and its biosimilar GP40141 showed similar results.

作者简介

Alina Afanasyeva

Сlosed Joint-Stock Company “Farm-Holding”

编辑信件的主要联系方式.
Email: Alina.Afanaseva@geropharm.com
ORCID iD: 0000-0002-1443-4294

Junior Researcher, CJSC Pharm-Holding

俄罗斯联邦, Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, 198515

Valeria Saparova

Сlosed Joint-Stock Company “Farm-Holding”; A.I. Yevdokimov Moscow State University of Medicine and Dentistry

Email: Valeriya.Saparova@geropharm.com
ORCID iD: 0000-0002-8445-1129

Head of the Laboratory of Pharmacology, CJSC Pharm-Holding; researcher,A.I. Yevdokimov Moscow State University of Medicine and Dentistry

俄罗斯联邦, Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, 198515; Bld. 1, 20, Delegatskaya Str., Moscow, 127473

Jina Karal-Ogly

Scientific Research Institute of Medical Primatology

Email: karal_5@mail.ru
ORCID iD: 0000-0003-3606-1668

Candidate of Sciences (Biology), Deputy Director for Science,Scientific Research Institute of Medical Primatology

俄罗斯联邦, Bld. 177, Mir Str., Vesyoloye Vil., Sochi, 354376

Evgenia Mukhametzyanova

Scientific Research Institute of Medical Primatology

Email: evg.m89@mail.ru
ORCID iD: 0000-0002-1238-7594

Researcher,Scientific Research Institute of Medical Primatology

俄罗斯联邦, Bld. 177, Mir Str., Vesyoloye Vil., Sochi, 354376

Denis Kurkin

Volgograd State Medical University

Email: strannik986@mail.ru
ORCID iD: 0000-0002-1116-3425

Doctor of Sciences (Pharmacy), Associate Professor, Professor of the Department of Clinical Pharmacology and Intensive Care,VolgogradState Medical University, First Deputy Director of the Scientific Center for Innovative Medicines, Volgograd State Medical University

俄罗斯联邦, 1, Pavshikh Bortsov Sq., Volgograd, 400131

Anna Kalatanova

Сlosed Joint-Stock Company “Farm-Holding”

Email: Anna.Kalatanova@geropharm.com
ORCID iD: 0000-0003-2623-6014

Researcher, CJSC Pharm-Holding

俄罗斯联邦, Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, 198515

Igor Makarenko

Сlosed Joint-Stock Company “Farm-Holding”; A.I. Yevdokimov Moscow State University of Medicine and Dentistry

Email: Igor.Makarenko@geropharm.com
ORCID iD: 0000-0003-2308-0608

Candidate of Sciences (Medicine), Head of the Medical Department, CJSC Pharm-Holding; researcher,A.I. Yevdokimov Moscow State University of Medicine and Dentistry

俄罗斯联邦, Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, 198515; Bld. 1, 20, Delegatskaya Str., Moscow, 127473

Alexander Khokhlov

Yaroslavl State Medical University

Email: al460935@yandex.ru
ORCID iD: 0000-0002-0032-0341

Academician of the Russian Academy of Sciences, Professor, Doctor of Sciences (Medicine), Head of the Department of Clinical Pharmacology and Ethics of the Use of Medicines at UNESCO; Rector,Yaroslavl State Medical University

俄罗斯联邦, 5, Revolutsionnaya Str., Yaroslavl, 150000

Ilya Lugovik

Сlosed Joint-Stock Company “Farm-Holding”

Email: Ilia.Lugovik@geropharm.com
ORCID iD: 0000-0003-3840-5049

Researcher, CJSC Pharm-Holding

俄罗斯联邦, Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, 198515

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版权所有 © Afanasyeva A., Saparova V., Karal-Ogly J., Mukhametzyanova E., Kurkin D., Kalatanova A., Makarenko I., Khokhlov A., Lugovik I., 2023

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