Open AccessTHE CLINICAL DEVELOPMENT OF BIO-SIMILAR PRODUCTS OF INSULIN AND ITS ANALOGUES: MODERN STAGE OF PROGRESSING
Author(s) -
Anastasiya V. Philippova,
Филиппова Анастасия Владимировна,
Вэнь Чжао,
Вэнь Чжао,
А. С. Колбин,
Колбин А. С
Publication year - 2017
Publication title -
rossijskij medicinskij žurnal
Language(s) - English
Resource type - Journals
eISSN - 2412-9100
pISSN - 0869-2106
DOI - 10.18821/0869-2106-2017-23-5-269-274
Subject(s) - adaptation (eye) , medline , perspective (graphical) , insulin , russian federation , field (mathematics) , medicine , computer science , political science , psychology , geography , regional science , artificial intelligence , law , mathematics , neuroscience , pure mathematics
The article presents a review of data concerning clinical development of bio-similar products of recombinant human insulin and its analogues according beginning of 2017. The review is implemented concerning regulative requirements. The analysis is implemented concerning registries of registered medications and registries of clinical studies at the territory of the Russian Federation, European Union and USA. The review of articles in the information database MEDLINE (PubMed) is implemented too. It is established that in whole in the world regulative approaches are developed related to implementation of clinical studies of bio-similar products of insulin. However, this direction represents a new field of knowledge. The requirements to clinical studies of this type pass a stage of formation and adaptation. In the beginning of 2017 at the mentioned territories only two bio-similar insulin glargin were registered. At the same time, certain clinical studies at the present moment wait for completion. This situation testifies that the considered problem is one of the most actual and perspective fields of medical science.