IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG?
The possibility of extrapolation of indications for biosimilars is one of the issues widely discussed in modern literature. Currently, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have identified specific conditions under which for biosimilars extrapolation of indic...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
QUASAR, LLC
2016-06-01
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| Series: | Issledovaniâ i Praktika v Medicine |
| Subjects: | |
| Online Access: | https://www.rpmj.ru/rpmj/article/view/137 |
| _version_ | 1797874130396119040 |
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| author | S. V. Orlov N. L. Shimanovskii S. N. Fogt |
| author_facet | S. V. Orlov N. L. Shimanovskii S. N. Fogt |
| author_sort | S. V. Orlov |
| collection | DOAJ |
| description | The possibility of extrapolation of indications for biosimilars is one of the issues widely discussed in modern literature. Currently, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have identified specific conditions under which for biosimilars extrapolation of indications is possible. In2015, athe first bioanalogue bevacizumab, (produced by JSC "BIOCAD"), has been registered. The article provides summary of the pivotal clinical study of Bevacizumab bioanalogue conducted in patients with non-small cell lung cancer. The article includes detailed scientific justification for the extrapolation of data on the efficacy, safety and immunogenicity obtained in the pivotal study to other indications, registered for the original bevacizumab drug. |
| first_indexed | 2024-04-10T01:25:53Z |
| format | Article |
| id | doaj.art-4c71844fa9994b60b1466bb1be0e7891 |
| institution | Directory Open Access Journal |
| issn | 2410-1893 |
| language | Russian |
| last_indexed | 2024-04-10T01:25:53Z |
| publishDate | 2016-06-01 |
| publisher | QUASAR, LLC |
| record_format | Article |
| series | Issledovaniâ i Praktika v Medicine |
| spelling | doaj.art-4c71844fa9994b60b1466bb1be0e78912023-03-13T09:34:59ZrusQUASAR, LLCIssledovaniâ i Praktika v Medicine2410-18932016-06-0132455210.17709/2409-2231-2016-3-2-6103IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG?S. V. Orlov0N. L. Shimanovskii1S. N. Fogt2Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. ПавловаРоссийский национальный исследовательский медицинский университет им. Н.И. Пирогова, МоскваБИОКАД, ЗАО, Санкт-ПетербургThe possibility of extrapolation of indications for biosimilars is one of the issues widely discussed in modern literature. Currently, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have identified specific conditions under which for biosimilars extrapolation of indications is possible. In2015, athe first bioanalogue bevacizumab, (produced by JSC "BIOCAD"), has been registered. The article provides summary of the pivotal clinical study of Bevacizumab bioanalogue conducted in patients with non-small cell lung cancer. The article includes detailed scientific justification for the extrapolation of data on the efficacy, safety and immunogenicity obtained in the pivotal study to other indications, registered for the original bevacizumab drug.https://www.rpmj.ru/rpmj/article/view/137бевацизумабезопасностьбиоаналогbcd-021немелкоклеточный рак легкогоэкстраполяция показанийэффективность |
| spellingShingle | S. V. Orlov N. L. Shimanovskii S. N. Fogt IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? Issledovaniâ i Praktika v Medicine бевацизума безопасность биоаналог bcd-021 немелкоклеточный рак легкого экстраполяция показаний эффективность |
| title | IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? |
| title_full | IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? |
| title_fullStr | IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? |
| title_full_unstemmed | IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? |
| title_short | IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? |
| title_sort | is it possible to use bevacizumab biosimilar in all indications registered for original drug |
| topic | бевацизума безопасность биоаналог bcd-021 немелкоклеточный рак легкого экстраполяция показаний эффективность |
| url | https://www.rpmj.ru/rpmj/article/view/137 |
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