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Биоаналоги: воспроизведение клинического профиля с помощью современных биотехнологий
- Source :
- Remedium. :8-24
- Publication Year :
- 2021
- Publisher :
- Joint-Stock Company Chicot, 2021.
-
Abstract
- A biosimilar is a biological medicinal product whose active substance is a version of an active substance of the previously authorised biological medicinal product. The approach taken to develop biosimilar products is fundamentally different from the one used for a new biological medicinal product because the main efforts are directed towards reproducing the original active substance to the greatest possible extent. The biosimilarity concept recognises that it is impossible to reproduce the original biopharmaceutical in full. Thus, it allows for certain differences if they do not cause a significant negative impact from the clinical point of view. To show biosimilarity, an extensive analytical testing program should be implemented where all detected differences are then evaluated in the functional assays. The subsequent non-clinical or clinical tests are needed to demonstrate that the biosimilar delivers the same clinical effect as the reference biological product, but not to prove, yet again, the safety and efficacy of the biological active substance per se by reproducing the development program of the reference biologic.
- Subjects :
- 0301 basic medicine
Clinical tests
Computer science
Comparability
Biosimilar
Biological product
030226 pharmacology & pharmacy
03 medical and health sciences
030104 developmental biology
0302 clinical medicine
Biopharmaceutical
General Materials Science
Product (category theory)
Biochemical engineering
Analytical Testing
Subjects
Details
- ISSN :
- 26583534 and 15615936
- Database :
- OpenAIRE
- Journal :
- Remedium
- Accession number :
- edsair.doi...........c140b81bc09ecc9af6c5d1824f722fb3