Питання безпеки біосимілярів аналогів інсулінів: факти та побоювання

Technical progress in the field of biology and medicine radically changed the forecast of numerous serious diseases and the fate of patients, which is associated with the  evelopment and clinical application of biopharmaceutical drugs. Today, the term of a molecular patent is expired in a number of biological agents, that have become a key factor in the development of so-called biosimilars, representing reproduced versions of original biotechnological tools. Since biosynthetic drugs appearing as a biosimilar replacementcan, although slightly, differ in the production process (variations in immunogenicity, safety and / or efficacy), a clear understanding of the clinical and regulatory aspects of the original drugs and biological analogues is of the utmost importance. According to the forecasts of statisticians, the share of biosimilars from the volume of the biopharmaceutical market will constantly grow and by 2020 can reach 40%, which in money terms will be more than $100 billion. According to the forecasts of statisticians, the share of biosimilars in the volume of the biopharmaceutical market will constantly grow and by 2015-2020 can reach 40%, which in money terms will be more than $100 billion. Among the factors of the development of biosimilar market is a moderate price compared to that of original products, a wide range of applications, an increase of the state interest. The differences between the original preparation, generic and biosimilar are showed in the article. The regulatory base of biosimilars registration in Ukraine is also presented, which is now harmonized with European legislation. In general, the introduction of biosimilars into medical practice will significantly reduce the cost for health care, and, consequently, the cost of these medicines for the population. However, the peculiarities of the structure, synthesis and production of biopharmaceutical drugs require a careful approach to assess their quality, efficacy and safety.