MONOCLONAL ANTIBODY AT THE PHARMACEUTICAL MARKET OF UKRAINE

Abstract

Monoclonal antibodies are a rapidly developing new class of medicines that have been shown to be effective in treating many serious diseases. Currently, monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, severe bronchial asthma and chronic obstructive pulmonary disease are being developed. Therapy of infectious diseases using monoclonal antibodies is promising. Monoclonal antibodies are developed using various technologies, and they are classified as «murine», chimeric, humanized, and human. The most modern, effective and safe are human monoclonal antibodies, which account for more than half of the global therapeutic market. The aim of this study was to analyze and structure information regarding the assortment and availability of monoclonal antibodies in the pharmaceutical market of Ukraine and in healthcare institutions. Materials and methods. The analysis of the assortment of monoclonal antibodies available on the Ukrainian pharmaceutical market as of April-June 2024 was conducted based on the data from the State Register of Medicinal Products of Ukraine. We used informational, comparative, systemic, analytical, marketing and other methods of analysis. The accessibility of medicines was characterised by the availability of the medicament at the place of service on the day of data collection. Results and discussion. As of April-June 2024, 40 INNs of monoclonal antibodies and their conjugates with medicinal products were registered in the Ukrainian pharmaceutical market. «Murine» and bispecific monoclonal antibodies are not registered in the pharmaceutical market of Ukraine. 1–2 brand names are registered for most antibodies in Ukraine, with the exception of rituximab, trastuzumab, bevacizumab, and adalimumab, for which three or more brand names are registered. These are mainly antineoplastic and immunomodulatory agents. All monoclonal antibodies present on the Ukrainian pharmaceutical market are produced outside Ukraine. Monoclonal antibodies are represented in Ukraine by parenteral dosage forms. Trastuzumab and rituximab have the largest number of dosage forms. The majority of monoclonal antibodies are registered in a single dosage form. Denosumab, adalimumab and rituximab are the most widely available in pharmacies and healthcare institutions by different regions of Ukraine, while infliximab, ustekinumab, golimumab and emicizumab are the least available. Hospitals offer a limited range of monoclonal antibody products. Some monoclonal antibody medicines are not available in Ukraine or are available in only a few healthcare institutions. Kyiv and Kyiv region have the best supply of monoclonal antibodies. This region is characterised by a wide range of products. Kherson and Sumy regions are poorly supplied with antibodies (some healthcare facilities with a narrow range of products). Conclusions. An analysis of the assortment of monoclonal antibodies in the pharmaceutical market of Ukraine has been conducted. 40 INNs of monoclonal antibodies, exclusively of foreign production, were registered in Ukraine as of April-June 2024. In fact, 31 INNs of monoclonal antibodies are available in pharmacies, and 10 INNs in hospitals. The main pharmacotherapeutic focus of this group of medicines is the treatment of malignant tumours. Only parenteral monoclonal antibody drugs are available on the pharmaceutical market. The regions of Ukraine are unevenly supplied with monoclonal antibodies. The most common medicines are denosumab, adalimumab and rituximab. Some monoclonal antibody medicines are not available in Ukraine or are available in only a few healthcare institutions.