Glycemia under control

Diabetes mellitus (DM) has become a global and national menace. The number of patients with diabetes in the Russian Federation tallied roughly 5.1 million, according to the incidence of outpatient visits in 2020 [1]. “Do-it-yourself” regular measurements of blood glucose levels (self-monitoring) are one of the most important components in achieving the therapy goals for patients with diabetes and preventing severe vascular complications. Now that the technologies have caught on, new “smart” glucometers appeared, which enable remote control and significantly expand opportunities of DM monitoring due to free mobile application integration.

Russian marketing analysis of biologically active additives with pancreatic enzyme

The Russian market of biologically active additives, which include pancreatine and pancreatic enzymes — amylase, protease, lipase, has been analyzed. It was established that the study group is represented by a wide range (approximately 150 names), which is represented mainly by foreign manufacturers (approximately 80%). The monotonous tendency to increase sales by volume in all regions of the Russian Federation over the past 5 years has been analyzed. It should be noted that, today consumer preferences biologically active additives of domestic production despite the significant share of imported dietary supplements in the supply structure. High demand is primarily due to the accessibility and increased trust and loyalty of modern consumers to national producers of biologically active additives .

Issues of pharmaceutical specialist admission to work

A study was carried out to identify differences in training of resident physicians in the specialties: Management and Economics of Pharmacy, Pharmaceutical Technology, Pharmaceutical Chemistry and Pharmacognosy and under the specialist’s program Pharmacy and to explore the possibilities of granting pharmacy workers the right to transit from one specialty to another without compulsory completion of residency. The urgency of this article is associated with a large number of issues that are being faced by pharmacists who transit from one specialty to another.An analysis of the age and occupational structure of pharmacists improving their qualifications (2300 people) was conducted in the Irkutsk region and the Trans-Baikal Territory. The results of the study showed that it seems like a good idea not to associate the transition from one specialty to another with the obligatory completion of residency, but to provide an admission to work as a pharmacist-technologist after initial accreditation, taking into account the specifics of the work of pharmaceutical specialists in pharmacies, the need to ensure the interchangeability of workers and reduce staff turnover without falling off in quality of work.

Study of the availability of gene therapeutic drugs in the Russian Federation

The authors studied the availability of gene therapy drugs in the Russian Federation on the basis of information on the permission of the medical use of drugs of this group in the world. Literature data and information about medicines approved by the FDA, EMA and the Ministry of Health of Russia were used. In general, the FDA registered only 13 drugs (46%) of the total approved for medical use in the world, 2 of them have already been withdrawn from the market, and 2 additional clinical trials are underway. In Europe, the EMA has approved 16 drugs for medical use (57%), with 4 of them already withdrawn. Most of the drugs were first approved by the FDA, and then, on average, a year later, were approved in the European market. A total of 4 drugs were approved in the European market and were not approved by the FDA at the time the data was requested. And only 1 drug, approved in the USA, is not registered in Europe. In the Russian Federation, two medicines are allowed, Neovasculgen (2011) and Spinraza (2019). This is only 7% of the total number of gene therapy drugs on the world market. Most of the drugs are intended for the treatment of orphan diseases and are cost expensive. This can explain the unevenness of their distribution across regions.

Financial results of pharmaceutical industry: 2020

Financial status is the most important characteristic of the economic activity of the industry enterprises, which determines its economic attractiveness. Let us consider a set of indicators reflecting the availability, placement and use of financial resources of enterprises in the industry.Financial status of pharmaceutical companies is analysed using the data form State Statistical Reporting Form No. P-3 – Information on Company Financial Status.

Overview of the Russian market of herbal products

Introduction. In the Russian pharmaceutical market, there is the following situation: herbal medicinal products (HMP) and dietary supplements based on plant raw materials (DS) have similar compositions, dosage forms and scope of application. They’re often considered analogues by consumers and specialists, which indicates the existence of common market for these products.Research aim is to investigate the state and development trends of the Russian HMP and DS market, assessing positions of foreign and domestic companies and general prospects for this market as well.Methodology. The study was conducted using IQVIA retail audit database, official sources of information on HMP and DS registration. In the market analysis the products were classified depending on the scope of application, composition and preparation methods, and dosage forms as well.Results. In 2020 pharmacy of HMP and DS sales amounted to 435.4 million units valued at 51.3 billion rubles in wholesale prices. Beginning with 2016, the average annual growth rate corresponded to 4.2%, in value terms. However, in volume terms, the sales were reduced in the average by 3.4% per year (due to cheap domestic medicines). The main part of the entire market comprises HMP (80% in units and 74% in value terms in 2020). The products, affecting respiratory system, genitourinary sphere, and digestion, provide more than three-quarters of all sales in value terms. More than half of the market is occupied by total extractive drugs. Solid dosage forms (tablets and capsules) account for half of the sales, plant raw materials and fees constitute more than one third. In 2020, Russian companies provided 28% of the sales of HMP and 67% of DS in value terms. In the context of the main segments, the market structure in 2016-2020 remained fairly stable.Conclusion. In the future, the market dynamics in value terms will be determined considering by household income and the epidemiological situation. In units, HMP sales will continue to decline through the unprofitable positions of the traditional domestic drug assortment. The increasing strictness of legislation requirements for the market of dietary supplements may contribute to investment in the development of HMP that are competitive to foreign products in terms of quality and consumer characteristics.

A structural analysis of sales of drugs for the treatment of chronic hepatitis C in the Russian market

The World Health Organization reports that 3-4 mil. people are newly infected with hepatitis C virus per year, of which 70% will develop chronic HCV disease. Viral hepatitis is a significant burden on the state budget due to its prevalence among the working-age population. Increase of antiviral therapy coverage for patients diagnosed with chronic hepatitis C is one of the priorities of healthcare system. The paper presents the results of the analysis of trends in the sales pattern over 2016–2020. The objects of the study were State Register of Medicinal Products (as of February 24, 2020), clinical guidelines of the Ministry of Health of Russia on the pharmacotherapy of chronic hepatitis C, information database of the DSM Group analytical company.It has been established that the sales of drugs used for the treatment of chronic hepatitis C in the Russian pharmaceutical market tend to grow by 17.60% in value terms and 106.16% in physical terms during the period under consideration. At the same time, the composition of dasabuvir + ombitasvir + paritaprevir + ritonavir (in value terms) and ritonavir (in physical terms) accounts for the greatest share among international non-proprietary names. It was revealed that the products of foreign manufacturers prevail in the sales pattern. Abbvie, Johnson & Johnson and AstraZeneca are the leaders among the companies – manufacturers of drugs for the therapy of chronic hepatitis C in terms of sales. It was found that 84.62% of drugs used for the treatment of chronic hepatitis C are included into the VED list.

Pharmaceutical manufacturers ranking by sales profit for 2020

The amount of sales profit is one of the indicators of the manufacturer’s business performance. This is the financial result from the main activity of the manufacturer, which can be carried out in any form registered in its charter (and not prohibited by law). The product sales profit is defined as the difference between the proceeds from sales (without value added tax and excise taxes) and the costs of production and sales included in the product costs.

Biosimilars: evolution of approaches to the development, regulation, life cycle control and interchangeability management

The legal framework for biosimilar medicinal product was first established in 2004 in the European Union and later in the USA. Since then, based on the scientific and regulatory experience with biosimilarity assessment, regulatory approaches have evolved considerably. A clear understanding of the capabilities of each development stage in assessing comparability in terms of power to identify differences and assess their relevance to the final clinical outcome gradually accumulated. In addition to the commitment to the biosimilarity approach, it is important to comply with the general requirements applicable to any drugs produced at an industrial scale. Experience showed that the demonstration of biosimilarity based on a range of analytical and functional tests and mainly clinical pharmacological studies is universal and allows extrapolating therapeutic indications. The establishment of biosimilar interchangeability, since the active substance by definition is a version of the active substance of the corresponding reference biological product, can introduce additional difficulties. A single approach to the establishment of biosimilar interchangeability has not yet been developed.