Biosimilars: presumption of guilt
Some chronic systemic diseases, including diabetes mellitus, require the life-long use of biotechnological medical products, of which quality,effectiveness and safety depends the duration and quality of life for patients.Patent protection expiry of many original biological agents has assumed the key...
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Endocrinology Research Centre
2011-12-01
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doaj-b1538ef0741c4c26a0787930c70084142021-06-02T19:24:49ZengEndocrinology Research CentreСахарный диабет2072-03512072-03782011-12-01144919910.14341/2072-0351-58255783Biosimilars: presumption of guiltMarina Vladimirovna Shestakova0Olga Konstantinovna Vikulova1Endocrinology Research Centre, MoscowEndocrinology Research Centre, MoscowSome chronic systemic diseases, including diabetes mellitus, require the life-long use of biotechnological medical products, of which quality,effectiveness and safety depends the duration and quality of life for patients.Patent protection expiry of many original biological agents has assumed the key role in development of biosimilars (replica versions of originalbiotechnological products) and their broad entrance to the pharmaceutical market. Because of structural complexity of biological products andimpossibility of precise reproduction of patented processing, biosimilars are not ideal duplicates of original substances. Despite numerous evidence oftherapeutic nonequivalence, danger of mechanical substitution of original agents still exists in Russia due to lower price of biosimilars - and lackof legislative acts, regulating registration and circulation of such drugs.In this article we characterize biosimilars in great detail and review major problems of their use, that is: aspects of quality control; disparity withoriginal bio-agents in efficacy and safety; clinical trial requirements, registration procedures and subsequent safety control.https://dia-endojournals.ru/dia/article/viewFile/5825/3584biosimilarsbiotechnologybiotechnological agentsgenericsinsulinbiosimilar registration regulations |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Marina Vladimirovna Shestakova Olga Konstantinovna Vikulova |
spellingShingle |
Marina Vladimirovna Shestakova Olga Konstantinovna Vikulova Biosimilars: presumption of guilt Сахарный диабет biosimilars biotechnology biotechnological agents generics insulin biosimilar registration regulations |
author_facet |
Marina Vladimirovna Shestakova Olga Konstantinovna Vikulova |
author_sort |
Marina Vladimirovna Shestakova |
title |
Biosimilars: presumption of guilt |
title_short |
Biosimilars: presumption of guilt |
title_full |
Biosimilars: presumption of guilt |
title_fullStr |
Biosimilars: presumption of guilt |
title_full_unstemmed |
Biosimilars: presumption of guilt |
title_sort |
biosimilars: presumption of guilt |
publisher |
Endocrinology Research Centre |
series |
Сахарный диабет |
issn |
2072-0351 2072-0378 |
publishDate |
2011-12-01 |
description |
Some chronic systemic diseases, including diabetes mellitus, require the life-long use of biotechnological medical products, of which quality,effectiveness and safety depends the duration and quality of life for patients.Patent protection expiry of many original biological agents has assumed the key role in development of biosimilars (replica versions of originalbiotechnological products) and their broad entrance to the pharmaceutical market. Because of structural complexity of biological products andimpossibility of precise reproduction of patented processing, biosimilars are not ideal duplicates of original substances. Despite numerous evidence oftherapeutic nonequivalence, danger of mechanical substitution of original agents still exists in Russia due to lower price of biosimilars - and lackof legislative acts, regulating registration and circulation of such drugs.In this article we characterize biosimilars in great detail and review major problems of their use, that is: aspects of quality control; disparity withoriginal bio-agents in efficacy and safety; clinical trial requirements, registration procedures and subsequent safety control. |
topic |
biosimilars biotechnology biotechnological agents generics insulin biosimilar registration regulations |
url |
https://dia-endojournals.ru/dia/article/viewFile/5825/3584 |
work_keys_str_mv |
AT marinavladimirovnashestakova biosimilarspresumptionofguilt AT olgakonstantinovnavikulova biosimilarspresumptionofguilt |
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