CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA®
Objective. Evaluation of pharmacokinetics, pharmacodynamics, safety and efficacy of rituximab biosimilar (Acellbia, BIOCAD, Russia) used as monotherapy in patients with indolent B-cell non-Hodgkin’s lymphoma in comparison with the parameters of innovator rituximab – MabThera.Materials and methods....
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QUASAR, LLC
2015-04-01
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| Series: | Исследования и практика в медицине |
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| Online Access: | https://www.rpmj.ru/rpmj/article/view/30 |
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| author | S. M. Alekseev K. D. Kaplanov R. A. Ivanov E. V. Chernyaeva |
| author_facet | S. M. Alekseev K. D. Kaplanov R. A. Ivanov E. V. Chernyaeva |
| author_sort | S. M. Alekseev |
| collection | DOAJ |
| description | Objective. Evaluation of pharmacokinetics, pharmacodynamics, safety and efficacy of rituximab biosimilar (Acellbia, BIOCAD, Russia) used as monotherapy in patients with indolent B-cell non-Hodgkin’s lymphoma in comparison with the parameters of innovator rituximab – MabThera.Materials and methods. 92 patients (aged 18 years and older with diagnosed CD20-positive follicular non-Hodgkin’s lymphoma, stage II-IV by Ann Arbor, 1-2 histologic grade, or marginal zone lymphoma) were enrolled into the study. Patients were randomised in 1:1 ratio to receive 375 mg/sq.m of Acellbia or MabThera on days 1, 8, 15 and 22.Results. Overall response rate in both arms was equivalent: 39.52% in BCD-020 arm and 36.57% of patients in RTX arm (p=0.8250). Within the first week after a single infusion of Acellbia or MabThera, the level of CD19 and CD20-positive cells rapidly decreased to almost undetectable values without any obvious recovery by the end of observation (upon intergroup comparison p>0.05 at all specified time points). 90% CI for the geometric mean of a Acellbia/MabThera AUC0-t ratio fell within standard bioequivalence range 80-125% (80.1-118.2% for the ratio of AUC0-168 after a single dose). Within the whole study period the frequency of AEs, including severe AEs (grade 3-4), associated with the use of monotherapy, were equal in both arms without any significant differences. Conclusions. Acellbia is non-inferior to MabThera in terms of efficacy, pharmacokinetics, pharmacodynamics and immunogenicity. Acellbia was well tolerated, with the safety profile comparable with MabThera’s parameters. |
| format | Article |
| id | doaj-art-7616405cadf64c2a9ad434b29255cf2b |
| institution | Kabale University |
| issn | 2410-1893 |
| language | Russian |
| publishDate | 2015-04-01 |
| publisher | QUASAR, LLC |
| record_format | Article |
| series | Исследования и практика в медицине |
| spelling | doaj-art-7616405cadf64c2a9ad434b29255cf2b2025-02-03T07:12:18ZrusQUASAR, LLCИсследования и практика в медицине2410-18932015-04-012181210.17709/2409-2231-2015-2-1-8-1214CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA®S. M. Alekseev0K. D. Kaplanov1R. A. Ivanov2E. V. Chernyaeva3Research Institute of Oncology named after N.N. Petrov (Saint-Petersburg, Russian Federation) 68, Leningradskaya Str, Pesochniy, St.Petersburg, Russian Federation, 197758State Healthcare Institution Volgograd Regional Clinical Oncology Dispensary (Volgograd, Russian Federation) 78, Zemlyachki, Volgograd, Russian Federation, 400138CJSC BIOCAD (Saint-Petesburg, Russian Federation) Ul. Svyazi 34-A, Strelna, Saint-Petesburg, Russian Federation,198515CJSC BIOCAD (Saint-Petesburg, Russian Federation) Ul. Svyazi 34-A, Strelna, Saint-Petesburg, Russian Federation,198515Objective. Evaluation of pharmacokinetics, pharmacodynamics, safety and efficacy of rituximab biosimilar (Acellbia, BIOCAD, Russia) used as monotherapy in patients with indolent B-cell non-Hodgkin’s lymphoma in comparison with the parameters of innovator rituximab – MabThera.Materials and methods. 92 patients (aged 18 years and older with diagnosed CD20-positive follicular non-Hodgkin’s lymphoma, stage II-IV by Ann Arbor, 1-2 histologic grade, or marginal zone lymphoma) were enrolled into the study. Patients were randomised in 1:1 ratio to receive 375 mg/sq.m of Acellbia or MabThera on days 1, 8, 15 and 22.Results. Overall response rate in both arms was equivalent: 39.52% in BCD-020 arm and 36.57% of patients in RTX arm (p=0.8250). Within the first week after a single infusion of Acellbia or MabThera, the level of CD19 and CD20-positive cells rapidly decreased to almost undetectable values without any obvious recovery by the end of observation (upon intergroup comparison p>0.05 at all specified time points). 90% CI for the geometric mean of a Acellbia/MabThera AUC0-t ratio fell within standard bioequivalence range 80-125% (80.1-118.2% for the ratio of AUC0-168 after a single dose). Within the whole study period the frequency of AEs, including severe AEs (grade 3-4), associated with the use of monotherapy, were equal in both arms without any significant differences. Conclusions. Acellbia is non-inferior to MabThera in terms of efficacy, pharmacokinetics, pharmacodynamics and immunogenicity. Acellbia was well tolerated, with the safety profile comparable with MabThera’s parameters.https://www.rpmj.ru/rpmj/article/view/30rituximabbiosimilaracellbia®non-hodgkin’ lymphomab-cell depletion |
| spellingShingle | S. M. Alekseev K. D. Kaplanov R. A. Ivanov E. V. Chernyaeva CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® Исследования и практика в медицине rituximab biosimilar acellbia® non-hodgkin’ lymphoma b-cell depletion |
| title | CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® |
| title_full | CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® |
| title_fullStr | CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® |
| title_full_unstemmed | CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® |
| title_short | CURRENT APPROACH TO DEVELOPMENT OF BIOSIMILAR PRODUCTS CONTAINING MONOCLONAL ANTIBODIES AS AN ACTIVE SUBSTANCE – NON-CLINICAL AND CLINICAL STUDIES OF THE FIRST RUSSIAN RITUXIMAB BIOSIMILAR, ACELLBIA® |
| title_sort | current approach to development of biosimilar products containing monoclonal antibodies as an active substance non clinical and clinical studies of the first russian rituximab biosimilar acellbia r |
| topic | rituximab biosimilar acellbia® non-hodgkin’ lymphoma b-cell depletion |
| url | https://www.rpmj.ru/rpmj/article/view/30 |
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