No 3 (2021)

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Articles
State support of export for enterprises of the medical and pharmaceutical industry
Gertsik Y.G.
Abstract
The pharmaceutical and medical industries of Russia are socially significant and high-tech industries that have great potential for the development of non-primary exports. This paper examines the existing measures of state support for the development of the export potential of Russian manufacturers of medicines and medical devices, including measures provided for by the national projects “Health”, “International Cooperation and Export” and the strategy “Pharma-2030”. The relevance of the study is caused by the necessity to achieve national development goals, which include improving the quality and life expectancy of the country’s population as well. Recommendations are also formulated for the implementation of export projects, taking into account the industry specifics.
REMEDIUM. 2021;(3):6-10
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Overview of the Russian market of herbal products
Safonova N.V., Trofimova E.O.
Abstract
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.
REMEDIUM. 2021;(3):11-22
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Reyting aptechnykh setey Rossii po itogam I–II kv. 2021 goda
Bespalov N., Rasshchupkin P.
Abstract
Центральным событием 2021 г. в российском фармацевтическом ретейле, наверное, станет приобретение компанией «Катрен» контроля в сети «Эркафарм». Сделка интересна не столько прецедентом и размерами, сколько фактическим стартом активных консолидационных процессов в отрасли, и едва ли другие оптовые компании могут остаться в стороне от этих тенденций. Причем если до этого момента флагманы рынка предпочитали развивать розничные подразделения органическим путем, то сейчас ситуация может измениться, и, вероятно, мы увидим другие крупные сделки. Тем более что интересы «Катрен» в фармретейле выходят далеко за пределы «Эркафарм» и «Мелодии здоровья», основной актив здесь, безусловно, «Аптека.ру», которая за первую половину текущего года приросла на 4,5 тыс. новых участников и сейчас объединяет без малого 30% российских аптек. Наверное, сейчас многих волнует, как именно будет реализован этот потенциал.
REMEDIUM. 2021;(3):23
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Ol'ga VOROB'EVA: «Trevoga i depressiya v znachitel'noy stepeni ukhudshayut kachestvo zhizni patsienta»
- -.
Abstract
Традиционно 22 июля мир отметил День мозга, посвященный повышению осведомленности населения планеты о важности здоровья мозга и о наиболее распространенных заболеваниях головного мозга и нервной системы, включая патологическую тревогу. О проблемах пациентов, страдающих тревожными состояниями, и современных подходах к их лечению мы решили поговорить с Ольгой ВОРОБЬЕВОЙ, профессором кафедры нервных болезней ИПО Первого МГМУ им. И.М. Сеченова, специалистом высшей квалификационной категории, д.м.н.
REMEDIUM. 2021;(3):24-26
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A structural analysis of sales of drugs for the treatment of chronic hepatitis C in the Russian market
Tsitlionok E.A., Narkevich I.A., Nemyatykh O.D., Siukaeva D.D., Grinyuk A.S., Lisachenko V.O.
Abstract
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.
REMEDIUM. 2021;(3):28-34
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Svetlana YuRENEVA: «V kazhdom konkretnom sluchae vrach dolzhen individual'no podkhodit' k otsenke zdorov'ya patsientki»
- -.
Abstract
Гормональные противозачаточные таблетки, разработанные более 60 лет назад, совершили настоящую революцию в контрацепции. С тех пор медицина шагнула далеко вперед, и сегодня женщины имеют возможность применять безопасные и удобные контрацептивы при планировании беременности. Серьезные шаги были сделаны и в развитии менопаузальной гормональной терапии, играющей значительную роль в сохранении здоровья женщин зрелого возраста.О современных подходах к сохранению женского здоровья, в т. ч. в условиях пандемии COVID-19, мы решили поговорить со Светланой ЮРЕНЕВОЙ, д.м.н., ведущим научным сотрудником отделения гинекологической эндокринологии, профессором кафедры акушерства и гинекологии ФГБУ «НМИЦ акушерства, гинекологии и перинатологии имени В.И. Кулакова».
REMEDIUM. 2021;(3):35-38
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Andrey DANILOV: «Khronicheskaya bol' – eto uzhe ne epidemiya, a pandemiya»
- -.
Abstract
Боль остается наиболее частой жалобой пациентов, сопровождая почти 70% всех известных заболеваний1 и значительно ухудшая качество жизни миллионов людей в мире. В то же время, по статистике, от 30 до 80% пациентов не получают адекватного обезболивания2. Прояснить сложившуюся ситуацию мы попросили Андрея ДАНИЛОВА, профессора кафедры нервных болезней Института профессионального образования Первого МГМУ им. И.М. Сеченова, члена Международной ассоциации по изучению боли (International Association for the Study of Pain), главного редактора журнала «Manage Pain».
REMEDIUM. 2021;(3):40-42
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Russian marketing analysis of biologically active additives with pancreatic enzyme
Narkevich I.A., Nemyatykh O.D., Basakina I.I., Fitisova A.I.
Abstract
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 .
REMEDIUM. 2021;(3):44-49
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Ol'ga ZhUKOVA: «Vse kozhnye zabolevaniya sushchestvenno vliyayut na kachestvo zhizni patsientov»
- -.
Abstract
По разным оценкам, до 10% всех обращений в медицинские учреждения связаны с дерматозами – обширной группой заболеваний, включающей свыше 2000 нозологий. О некоторых наиболее часто встречающихся кожных болезнях, а также проблеме в целом мы беседуем с Ольгой ЖУКОВОЙ, главным врачом Московского научно-практического центра дерматовенерологии и косметологии Департамента здравоохранения г. Москвы, д.м.н.
REMEDIUM. 2021;(3):50-52
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Glycemia under control
Kalinina N.
Abstract
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.
REMEDIUM. 2021;(3):54-55
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Biosimilars: evolution of approaches to the development, regulation, life cycle control and interchangeability management
Niyazov R.R., Dranitsyna M.A., Vasiliev A.N., Gavrishina E.V.
Abstract
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.
REMEDIUM. 2021;(3):56-68
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Study of the availability of gene therapeutic drugs in the Russian Federation
Koshechkin K.A., Romanov P.A., Mokhov A.A., Khokhlov A.L.
Abstract
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.
REMEDIUM. 2021;(3):69-75
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Issues of pharmaceutical specialist admission to work
Moroz T.L., Ryzhova O.A.
Abstract
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.
REMEDIUM. 2021;(3):76-80
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Financial results of pharmaceutical industry: 2020
Romanova S.
Abstract
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.
REMEDIUM. 2021;(3):81-86
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Pharmaceutical manufacturers ranking by sales profit for 2020
Romanova S.
Abstract
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.
REMEDIUM. 2021;(3):87-91
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Igor' Rudinskiy: farmbiznes s chelovecheskim litsom
Vishlenkova E.A., Zatravkin S.N.
Abstract
До 2014 г. на российском фармацевтическом рынке «СИА» Интернейшнл» была второй по величине и успешности компанией. Ее мозгом, нервом, лицом и душой был владелец – Игорь Феликсович Рудинский. О нем вспоминают как о фантастическом человеке, говорят либо очень серьезно: «Игорь Феликсович был one man show1, гений. Он все держал в уме и сам всем управлял», либо иронически: «Вообще, с Игорем Рудинским было много интересных историй, талантливый был человек» [1]. Он сам создал «СИА» с нуля, сам владел, сам определял ее стратегию и тактику, сам участвовал в процессах, силой обаяния и опыта влиял на жизнь многих вовлеченных в фармбизнес людей. Судя по воспоминаниям, «СИА» Интернейшнл» была воплощением коммуникативных талантов Рудинского, его умения договариваться, его страсти к новому и неизведанному.
REMEDIUM. 2021;(3):93-98
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Orientatsiya na risk
Kuminova E.
Abstract
Несмотря на серьезное ухудшение эпидобстановки, российское здравоохранение пытаются вернуть к доковидной повестке – к достижению целевых показателей в области охраны здоровья, евразийской интеграции и международному сотрудничеству. О том, как изменится регуляторная среда российской медицины и фармы, представители федеральных ведомств и ЕЭК рассказали в ходе пленарного заседания XXIII Всероссийской конференции «Государственное регулирование в сфере обращения лекарственных средств и медицинских изделий».
REMEDIUM. 2021;(3):100-101
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Proizvodstvo meditsinskoy produktsii za aprel' 2021 goda
- -.
Abstract
REMEDIUM. 2021;(3):102
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Proizvodstvo meditsinskoy produktsii za may 2021 goda
- -.
Abstract
REMEDIUM. 2021;(3):103
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Farmatsevticheskaya reklama LP i BAD v rossiyskikh SMI v iyune 2021 goda
- -.
Abstract
По итогам июня 2021 г. в сегменте фармацевтической рекламы в категории «Лекарственные препараты и биологически активные добавки» (ЛП и БАД) на топ-20 рекламодателей суммарно по всем типам СМИ пришлось более 60 тыс. выходов рекламы, а на топ-20 марок ЛП и БАД – более 31 тыс. выходов.
REMEDIUM. 2021;(3):104
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