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.

На протяжении более полувека единственной группой антикоагулянтов для перорального применения, следовательно, удобными для амбулаторной практики были антагонисты витамина К, в частности, варфарин. Новые оральные антикоагулянты (НОАК), войдя около десяти лет назад в клиническую практику, стали достойной альтернативой антагонистам витамина К для профилактики и лечения венозных тромбоэмболических осложнений (ВТЭО) у пациентов кардиологического профиля и пациентов после больших ортопедических операций. К группе НОАК относят прямой

The article presents a review of publications implemented with the purpose to characterize immunogenic potential of medications of insulin: from preparations of animal origin to modern genetically engineered products. The review is presented concerning regulative requirements regulating control of insulin products safety. It is established that during evaluation of safety of insulin products the main attention is focused on issues of immunogenicity. The analysis of publications from open access in information database MEDLINE (Pubmed) was carried out, permitting to characterize immunogenic potential of insulin preparations. On balance, the review included 17 articles according the results of selection. It is established that information about immunogenic potential of insulin products is contradictory enough that can be determined by both characteristics of studies and technological particularities of production of medicinal insulin products. The modern preparations of analogs of insulin are in general comparative by their safety characteristics with medicinal preparations of human genetically engineered insulin. Among analogs of insulin the most immunogenic potential is specific to aspart and glargin. The cases of development of cross-reactive antibodies between various medicinal preparations of insulin are observed.