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...
Guardado en:
| Autores principales: | , |
|---|---|
| Formato: | article |
| Lenguaje: | EN RU |
| Publicado: |
Endocrinology Research Centre
2011
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/b1538ef0741c4c26a0787930c7008414 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:b1538ef0741c4c26a0787930c7008414 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:b1538ef0741c4c26a0787930c70084142021-11-14T09:00:16ZBiosimilars: presumption of guilt2072-03512072-037810.14341/2072-0351-5825https://doaj.org/article/b1538ef0741c4c26a0787930c70084142011-12-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/5825https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378Some 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.Marina Vladimirovna ShestakovaOlga Konstantinovna VikulovaEndocrinology Research Centrearticlebiosimilarsbiotechnologybiotechnological agentsgenericsinsulinbiosimilar registration regulationsNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 14, Iss 4, Pp 91-99 (2011) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN RU |
| topic |
biosimilars biotechnology biotechnological agents generics insulin biosimilar registration regulations Nutritional diseases. Deficiency diseases RC620-627 |
| spellingShingle |
biosimilars biotechnology biotechnological agents generics insulin biosimilar registration regulations Nutritional diseases. Deficiency diseases RC620-627 Marina Vladimirovna Shestakova Olga Konstantinovna Vikulova Biosimilars: presumption of guilt |
| 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. |
| format |
article |
| author |
Marina Vladimirovna Shestakova Olga Konstantinovna Vikulova |
| 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 |
| publishDate |
2011 |
| url |
https://doaj.org/article/b1538ef0741c4c26a0787930c7008414 |
| work_keys_str_mv |
AT marinavladimirovnashestakova biosimilarspresumptionofguilt AT olgakonstantinovnavikulova biosimilarspresumptionofguilt |
| _version_ |
1718429605166055424 |