Modern concepts of biosimilars in hematology and oncology
Biologics are large protein or polypeptide molecules produced by living organisms, which largely determine the efficiency of modern anticancertherapy. Biological products that destroy cancer cells and protect normal patient tissue led to progress in the treatment of breast cancer, colon cancer, kidn...
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| Format: | Article |
| Language: | Russian |
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ABV-press
2014-07-01
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| Series: | Онкогематология |
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| Online Access: | https://oncohematology.abvpress.ru/ongm/article/view/45 |
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| _version_ | 1849409264489070592 |
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| author | V. V. Ptushkin |
| author_facet | V. V. Ptushkin |
| author_sort | V. V. Ptushkin |
| collection | DOAJ |
| description | Biologics are large protein or polypeptide molecules produced by living organisms, which largely determine the efficiency of modern anticancertherapy. Biological products that destroy cancer cells and protect normal patient tissue led to progress in the treatment of breast cancer, colon cancer, kidney cancer, malignant lymphomas and other diseases. But the high cost and complexity of production limit their use. The expiration of patent protection for a number of biological products resulting to the possibility of reduces their costs when issuing an alternative manufacturer. At the same time, biosimilars are produced by living cells (as the original protein molecules), which led to serious difficulties in reaching their identity. The European Union has developed special registration rules for these preparations in order to avoid lack of efficacy or increased toxicity. They include regulations to determine the quality of biological products, requirements for pre-clinical and clinical studies, according to its specific characteristics, as well as the requirements for pharmacovigilance. Implementation of such a strategy has to register in the EU several biosimilars of granulocyte colonytimulating factor. For one of them – Zarzio – in several clinical studies fully comparable efficacy and tolerability with the original preparation was shown, thus providing a significant reduction of treatment cost with equal efficacy and toxicity. |
| format | Article |
| id | doaj-art-8cb8d34b2dc9499ca56beef153b2cd92 |
| institution | Kabale University |
| issn | 1818-8346 2413-4023 |
| language | Russian |
| publishDate | 2014-07-01 |
| publisher | ABV-press |
| record_format | Article |
| series | Онкогематология |
| spelling | doaj-art-8cb8d34b2dc9499ca56beef153b2cd922025-08-20T03:35:33ZrusABV-pressОнкогематология1818-83462413-40232014-07-0181596410.17650/1818-8346-2013-8-1-59-6460Modern concepts of biosimilars in hematology and oncologyV. V. Ptushkin0Dmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of RussiaBiologics are large protein or polypeptide molecules produced by living organisms, which largely determine the efficiency of modern anticancertherapy. Biological products that destroy cancer cells and protect normal patient tissue led to progress in the treatment of breast cancer, colon cancer, kidney cancer, malignant lymphomas and other diseases. But the high cost and complexity of production limit their use. The expiration of patent protection for a number of biological products resulting to the possibility of reduces their costs when issuing an alternative manufacturer. At the same time, biosimilars are produced by living cells (as the original protein molecules), which led to serious difficulties in reaching their identity. The European Union has developed special registration rules for these preparations in order to avoid lack of efficacy or increased toxicity. They include regulations to determine the quality of biological products, requirements for pre-clinical and clinical studies, according to its specific characteristics, as well as the requirements for pharmacovigilance. Implementation of such a strategy has to register in the EU several biosimilars of granulocyte colonytimulating factor. For one of them – Zarzio – in several clinical studies fully comparable efficacy and tolerability with the original preparation was shown, thus providing a significant reduction of treatment cost with equal efficacy and toxicity.https://oncohematology.abvpress.ru/ongm/article/view/45oncologybiological agentsbiosimilarsneutropeniagranulocyte colony-stimulating factorzarzio |
| spellingShingle | V. V. Ptushkin Modern concepts of biosimilars in hematology and oncology Онкогематология oncology biological agents biosimilars neutropenia granulocyte colony-stimulating factor zarzio |
| title | Modern concepts of biosimilars in hematology and oncology |
| title_full | Modern concepts of biosimilars in hematology and oncology |
| title_fullStr | Modern concepts of biosimilars in hematology and oncology |
| title_full_unstemmed | Modern concepts of biosimilars in hematology and oncology |
| title_short | Modern concepts of biosimilars in hematology and oncology |
| title_sort | modern concepts of biosimilars in hematology and oncology |
| topic | oncology biological agents biosimilars neutropenia granulocyte colony-stimulating factor zarzio |
| url | https://oncohematology.abvpress.ru/ongm/article/view/45 |
| work_keys_str_mv | AT vvptushkin modernconceptsofbiosimilarsinhematologyandoncology |