No 2 (2021)

Full Issue

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Articles
Biosimilars: reproduction of the clinical profile using modern biotechnology
Niyazov R.R., Dranitsyna M.A., Vasiliev A.N., Gavrishina E.V.
Abstract
A biosimilar is a biological medicinal product whose active substance is a version of an active substance of the previously authorised biological medicinal product. The approach taken to develop biosimilar products is fundamentally different from the one used for a new biological medicinal product because the main efforts are directed towards reproducing the original active substance to the greatest possible extent. The biosimilarity concept recognises that it is impossible to reproduce the original biopharmaceutical in full. Thus, it allows for certain differences if they do not cause a significant negative impact from the clinical point of view. To show biosimilarity, an extensive analytical testing program should be implemented where all detected differences are then evaluated in the functional assays. The subsequent non-clinical or clinical tests are needed to demonstrate that the biosimilar delivers the same clinical effect as the reference biological product, but not to prove, yet again, the safety and efficacy of the biological active substance per se by reproducing the development program of the reference biologic.
REMEDIUM. 2021;(2):8-24
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Russian pharmaceutical market as of the first quarter, 2021
Kalinina N., Shestovets A.
Abstract
Since a partially unfavourable epidemiological situation persists, the Russian pharmaceutical market remains one of the most steadily growing in terms of roubles. Feverish demand for drugs, enhancement of the role of the public segment, increase in importance and speed of adoption of legislative initiatives – all these factors have a significant impact on both the dynamics and conditions of the broader market, becoming not only a strength test for the pharmaceutical industry, but also a chance to implement new opportunities.
REMEDIUM. 2021;(2):25-29
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A review of tender purchases of L01 group – antineoplastic agents
Kalinina N.
Abstract
It is clear now that 2021 will be as challenging as the previous year. The pandemic continues, the economic situation has a negative effect on all markets as before, including the pharmaceutical one. All participants in the pharmaceutical market are undertaking their best efforts to maintain operating supply chains and to ensure uninterrupted provision of population with the necessary drugs. Concurrently, the public procurement situation will directly depend on the morbidity rate in the population.
REMEDIUM. 2021;(2):30-31
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Import of pharmaceutical substances to Russia in 2020
Nechaeva Y.
Abstract
Among other things, 2020 with all its challenges exposed high Russian pharma dependence on API imports, and showed a number of problems that domestic manufacturers may encounter.
REMEDIUM. 2021;(2):32-35
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Reyting aptechnykh setey Rossii po itogam I kvartala 2021 goda
Bespalov N., Rasshchupkin P.
Abstract
Май 2021 г. для представителей «большого» российского ретейла ознаменовался стартом очередной волны консолидационных процессов, фактически речь идет сразу о трех крупных сделках: «Магнит» договорился о покупке сети «Дикси», «Лента» приобретает сеть Billa, наконец, крупное объединение формируется за счет консолидации отдельных аспектов деятельности трех региональных ретейлеров Сибири и Дальнего Востока («Красный Яр», «Самбери» и «Слата»).
REMEDIUM. 2021;(2):36
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Innovatsii, izmenivshie paradigmu lecheniya raka molochnoy zhelezy
- -.
Abstract
За последние 20 лет произошел настоящий прорыв в лечении рака молочной железы (РМЖ), в результате которого значительно увеличилась продолжительность жизни больных и улучшилось ее качество. О том, как новые препараты изменили парадигму лечения РМЖ, мы решили узнать у Евгения ИМЯНИТОВА, руководителя референс-центра и заведующего отделом биологии опухолевого роста ФГБУ «НМИЦ онкологии им. Н.Н. Петрова», члена-корреспондента РАН, профессора, д.м.н.
REMEDIUM. 2021;(2):37-38
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Reproduktivnoe zdorov'e zhenshchiny: sovremennye realii
- -.
Abstract
Пандемия внесла существенные коррективы в привычные схемы работы гинекологов. О том, как сохранить репродуктивное здоровье женщин, несмотря на ограничительные меры и необходимость социальной изоляции, мы поговорили с Верой Прилепской, доктором медицинских наук, профессором, заслуженным деятелем науки Российской Федерации, руководителем научно-поликлинического отделения ФГБУ «НМИЦ АГП им. акад. В.И. Кулакова».
REMEDIUM. 2021;(2):39-40
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COVID-19: not by vaccine alone
Gandel V.
Abstract
A novel cornavirus infection declared by WHO a COVID-19 pandemic has set the task of raising funds to address the challenge posed by the novel coronavirus SARS-Cov-2 against civilization. The design of drugs with antiviral activity against the novel coronavirus has resulted in the development of several drug candidates. Remdesivir developed by the American company Gilead Sciences Inc. has become one of the first drug, upon which the decision on using it as a pharmacotherapeutic agent was reached. Initially, the drug was created in 2009 for the treatment of other viral diseases but did not show the expected activity. The further development and assessment of pharmacological activity was carried out with the encouragement of public investment in conjunction with and under guidance of the USA Department of Defence and some university laboratories.The findings of clinical trials conducted in different countries have shown the future-oriented outlook for remdesivir for the treatment of patients with COVID-19, which, however, left WHO underwhelmed, as a result it did not recommend the drug as a pharmacotherapy for novel coronavirus infection. After an expert analysis, the Ministry of Health of the Russian Federation included remdesivir in the list of drugs that can be used in the treatment of COVID-19 along with other drugs. The study of the features and circumstances of the launch of remdesivir to the pharmaceutical market allows us to come ever closer to the answer to the fundamental question of the 21st century: SARS-Cov-2 is a design of nature or the result of purposeful anthropogenic activity.
REMEDIUM. 2021;(2):43-50
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Mariya DAVYDOVSKAYa: «Patsienty s rasseyannym sklerozom imeyut shirokiy spektr problem – kak meditsinskogo, tak i sotsial'nogo plana»
- -.
Abstract
Рассеянный склероз (РС), несмотря на глобальные достижения в области терапии, остается тяжелым хроническим заболеванием, которое поражает наиболее активную часть населения с учетом возраста дебюта – людей молодого и работоспособного возраста, что ставит его в ряд важнейших медико-социальных проблем. Серьезный прорыв в его лечении обеспечили препараты, изменяющие течение рассеянного склероза (ПИТРС), первыми из которых стали препараты иммуномодулирующего действия: бета-интерфероны и глатирамера ацетат (1996–1999 гг.). О новых возможностях, которые пациенты получили с появлением этих препаратов, их применении сегодня и о ситуации с заболеваемостью РС в целом мы решили поговорить с Марией ДАВЫДОВСКОЙ, профессором кафедры неврологии, нейрохирургии и медицинской генетики ГБОУ ВПО «РНИМУ им. Н.И. Пирогова» Минздрава России, заместителем главного внештатного специалиста-невролога Департамента здравоохранения г. Москвы, заместителем директора по научной работе ГБУ МО «НПЦ КЭА МЗ МО», президентом НКО «МАВРС», д.м.н.
REMEDIUM. 2021;(2):53-56
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Gout: what's new in the clinical guidelines
Prozherina Y., Shirokova I.
Abstract
Over the past two decades we have seen a breakthrough in the study of gout, one of the most common inflammatory joint diseases representing a great challenge for both patients and the healthcare system. The international and Russian guidelines for the treatment of patients with gout have been improved and updated in the light of scientific achievements and their successful application in real practice. For example, the guidelines of the American College of Rheumatology (ACR) that discuss new strategies for managing patients with gout were changed and added in 2020 [1].
REMEDIUM. 2021;(2):58-61
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A current approach to the treatment of ulcerative colitis: updated recommendations of the American Gastroenterological Association
Vodovozov A.
Abstract
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that generally begins in young adulthood [1]. If left untreated, it can present with recurrent inflammations of the mucous membrane. Findings from population cohort studies show that UC follows a mild or moderate clinical course in most cases, the most active phase of the disease usually coincides in time with establishing diagnosis, followed by remission and exacerbation periods of varying length and intensity. Approximately 15% of patients may have an aggressive course of the disease, and 20% of such patients may require hospitalization due to the severity of the condition [2].
REMEDIUM. 2021;(2):62-68
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Modern principles in the diagnostics and treatment of iron deficiency anemia and iron deficiency in gastroenterological diseases: review of current clinical guidelines
Alekseeva O.P.
Abstract
Anemia is the most frequent systemic complication and extraintestinal manifestation of gastrointestinal diseases, which is likely to be a unique example of chronic iron deficiency combined with anemia of chronic disease. In this case, anemia is not just a laboratory marker, but a complication that requires appropriate diagnostic and therapeutic approaches. At the same time, many global clinical guidelines, including gastroenterological ones, do not contain up-to-date scientific information on the most effective drugs with a favourable safety profile – intravenous iron preparations, which can be used both to manage anemia and replenish iron stores. The evidence base on these drugs is growing fast due to qualitative studies as well as systematic reviews and meta-analyses.
REMEDIUM. 2021;(2):70-76
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Diabeticheskaya polineyropatiya – ot profilaktiki k patogeneticheski obosnovannomu lecheniyu
- -.
Abstract
Диабетическая полинейропатия (ДПН) – тяжелое осложнение сахарного диабета (СД), которое приводит к нарушению трудоспособности, ранней инвалидизации и смерти пациентов. О причинах развития ДПН и современных методах ее лечения мы попросили рассказать Александра АМЕТОВА, заведующего кафедрой ФГБОУ ДПО РМАНПО Минздрава России, сетевой кафедры ЮНЕСКО по теме «Биоэтика сахарного диабета», заслуженного деятеля науки РФ, д.м.н., профессора.
REMEDIUM. 2021;(2):79-80
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Lineyka «Kontur» — drayver rosta segmenta glyukometrov
Prozherina Y.
Abstract
Регулярный мониторинг уровня глюкозы в крови является важнейшей задачей для всех больных сахарным диабетом. Особенно остро данная проблема стоит на сегодняшний день, когда больные с СД отнесены к категории риска тяжелого течения COVID-19 [1]. На российском рынке представлен целый ряд современных и удобных в использовании глюкометров, позволяющих эффективно решать эту задачу и держать СД под контролем даже в непростых эпидемиологических условиях, когда возможность посещения врача может быть ограниченна.
REMEDIUM. 2021;(2):83
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Atrial fibrillation: key aspects of therapy and place of DOAC
Prozherina Y.
Abstract
Тhe past 2020 was marked by important events in cardiology. European experts (ESC) released updated guidelines for the diagnosis and treatment of atrial fibrillation (AF). The updated Russian guidelines for the treatment of atrial fibrillation and atrial flutter were published in the same 2020. Pride of place goes to the guidelines for the treatment of these diseases and the prevention of stroke by prescription of direct oral anticoagulants (DOAC).
REMEDIUM. 2021;(2):84-85
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On guard of skin health
Shestovets A.
Abstract
The problem of wound disinfection does not lose its relevance over time and affects a number of areas of medicine. Despite the obvious progress in the creation of disinfectant drugs (DD), the issue of destroying infectious agents on the damaged skin is currently quite acute.
REMEDIUM. 2021;(2):86-88
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Preparing a proposal on entering a drug in the VED list: highlights
Tolkushin A.G., Kholovnya-Voloskova M.E., Pogudina N.L.
Abstract
The modern system for the selection of drugs to be included in the federal restrictive lists (for example, in the vital and essential drugs list – VEDL) has increasingly improved. A comprehensive scoring assessment by criteria is introduced.This article discusses three scales that are decisive at the stage of preparing a proposal for discussing a drug to be included in VEDL:assessment of the quality of clinical trials, assessment of economic effects of using a drug and assessment of other (additional) data.In order a drug to gain a passing score and to increase the overall score on these scales, actions may be taken in the following directions:• inclusion of systematic reviews, meta-analyses and randomized clinical trials in the proposal and exclusion of case-control studies, cohort designs, case reports or case series, and expert opinion;• attention should be paid to the choice of a comparison drug, the target patient population, efficacy endpoints, types of costs and methods of cost accounting, as well as the time horizon and modelling method when planning and conducting clinical feasibility study and budget impact analysis;• local manufacturing content on the territory of Russia or support of leading authorities in the treatment of diseases, including chief external experts of the Ministry of Health, who consider it necessary to use the drug, including the use within the framework of healthcare standards and clinical guidelines.
REMEDIUM. 2021;(2):91-99
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Markirovka: perekhod na novyy uroven'
Kuminova E.
Abstract
Маркировка охватывает все больше отраслей рынка. Первого мая стартовал пилотный проект по кодированию биологически активных добавок (ПП №6731). Он продлится до 31 августа 2022 г. А 1 июля перестает действовать упрощенный механизм «обратной приемки лекарств»2, введенный в связи с техническими сбоями в системе МДЛП и возникшей в связи с этим дефектуры лекарств.
REMEDIUM. 2021;(2):100-101
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Pharmaceutical industry for 2020
Romanova S.
Abstract
The analysis of pharmaceutical enterprises is performed using the data of the state statistical reporting of the industry enterprises. According to Rosstat, the quantum index by type of economic activity with code 21 “Manufacture of drug products and materials used for medical purposes” in 2020 was estimated at 119.6% as compared to the previous year.
REMEDIUM. 2021;(2):102-106
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Pharmaceutical manufacturers ranking by gross profit in 2020
Romanova S.
Abstract
The gross profit is one of the quantitative criteria of business activity in absolute terms, which can be used to assess the results and efficiency of the main production activities of enterprises. The ranking will be based not only on the absolute indicators of pharmaceutical manufacturers, such as the gross profit volume of enterprises, but also on relative or specific indicators – the trends in these volumes. The manufacturers ranking will be determined using one of the mathematical methods, which is called the sum of rankings. The ranking was prepared using the state accounting data of the top 90 pharmaceutical manufacturers. It should be noted that only profitable industry enterprises were included in the ranking.
REMEDIUM. 2021;(2):107-110
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Dostupnost' vs innovatsii: v poiskakh balansa
Kuminova E.
Abstract
Руководители фармкомпаний обсудили проблему лекарственного обеспечения в рамках Российского фармацевтического форума в Санкт-Петербурге
REMEDIUM. 2021;(2):111-112
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Preemstvennost' pokoleniy: GxP-akademiya ob\"edinit opyt i znaniya farmatsevticheskikh inspektorov
Kaplya-Bubenets V.
Abstract
Проблема преемственности знаний и передачи высоких стандартов в области соблюдения требований GMP при производстве лекарственных препаратов и проведении инспекций фармзаводов теперь решена. В Москве открыта Евразийская академия надлежащих практик, которая поможет привести к общему знаменателю подходы к инспектированию на едином рынке ЕАЭС. Этот проект позволит удовлетворить высокую потребность в повышении квалификации не только GMP-инспектората, но и всех участников рынка.
REMEDIUM. 2021;(2):113-114
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Na PMEF byl podpisan ryad soglasheniy v oblasti farmatsevticheskoy i meditsinskoy promyshlennosti
Kuminova E.
Abstract
Петербургский международный экономический форум 2–5 июня 2021 г. стал первым и самым масштабным в мире деловым событием офлайн-формата после вынужденного перерыва из-за пандемии коронавируса. Как сообщает организатор форума Фонд Росконгресс, за четыре дня работы было подписано беспрецедентное количество соглашений – более 890, на общую сумму 4 трлн 266 млрд 600 млн руб.1 Для сравнения: в 2019 г. было подписано 745 соглашений на сумму 3 трлн 271 млрд руб. Мы подготовили краткий обзор соглашений в области фармацевтической и медицинской промышленности, достигнутых в ходе ПМЭФ-2021.
REMEDIUM. 2021;(2):115-117
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Proizvodstvo meditsinskoy produktsii za fevral' 2021 goda
- -.
Abstract
REMEDIUM. 2021;(2):118
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Proizvodstvo meditsinskoy produktsii za mart 2021 goda
- -.
Abstract
REMEDIUM. 2021;(2):119
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Farmatsevticheskaya reklama LP i BAD v rossiyskikh SMI v marte 2021 goda
- -.
Abstract
По итогам марта 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 107 тыс. выходов рекламы, а на топ-20 марок ЛП и БАД – более 40 тыс. выходов.
REMEDIUM. 2021;(2):120
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National research Institute of public health named after N. A. Semashko

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