Science in Russia
Main article: Science in Russia
Healthcare in Russia
Main article: Healthcare in Russia
2023
Russian biosimilars and generics against cancer occupied 60% of the total clinical research market in Russia
In 2023, for the first time in 5 years, starting from 2019, the number of clinical trials the Russian of biosimilars and generics bioequivalence oncology treatment for biosimilars reached 58%. This is almost 60% of the entire domestic market for antitumor developments. According to the analysis of the open data register of permits for clinical trials Ministry of Health RUSSIAN FEDERATION , over the past two years, the number of trials of domestic biosimilars and generics against cancer has grown almost 2 times: From 32 in 2021 to 54 in 2023. In 2022, there were 49 of them. This was announced on February 8, 2024 by the company. OnkoTarget
Not only the proportion of clinical bioequivalence studies characteristic of generics has increased, but also clinical trials of all phases in general - from I-th to IV-th. As a result, the total share of domestic developments in 2023 amounted to a record 83% (77 molecules). This is the highest figure in the last 5 years. So in 2019 - it was only 31% (41 molecules), in 2022 - 60% (64 molecules) of the total volume of clinical research against cancer. This speaks of the huge potential for import substitution. More and more Russian drugs are undergoing clinical trials, which means that they will soon go into circulation and will be able to replace imported drugs.
Already in 2023, according to the results of successful clinical trials, 4 of the first and so far the only generics in Russia were registered for the most popular anticancer drugs: Osimertinib, Axitinib, Ruxolitinib and Bozutinib. The first is used in the therapy of non-small cell lung cancer, the second - in the treatment of advanced renal cell carcinoma, Ruxolitinib - in myelofibrosis and polycythemia vera, Bosutinib - in chronic myeloid leukemia. According to the results of three quarters of 2023, these are the most popular drugs in Russia in the field of oncology. Osimertinib sales volume - 4.7 billion rubles, Ruxolitinib - 3 billion rubles, Aksitinib - 1.6 billion rubles, Bozutinib - 469 million rubles.
 | We have organized a scientific and production base that allows us to trace the entire chain of the life cycle of drugs, from development to the study of the stability of routine batches, from the production of pharmaceutical substances to the final dosage form. This is very important for the quality of drugs - to know and understand their characteristics, as well as to minimize risks, including during transportation. This distinguishes us favorably from foreign manufacturers. Our capacities allow us to quickly increase volumes and cover the growing demand for vital anticancer drugs. As of February 2024, we produce 65 types of drugs based on 32 INNs. More than 90% of our products are on the VED list, "said Elena Lazareva, Deputy General Director for Production at OnkoTarget. |  |
A generic of another popular drug in the field of oncology, Cabazitaxel, will also be produced here. Each drug will go into production at a different time. This will depend on the patent conditions for the original drug, the Russian regulatory framework, etc.
The need for antitumor drugs is increasing every year. According to the Moscow Research Oncological Institute. P.A. Herzen, the incidence of cancer in Russia since 2012 has increased by 17%, especially the big jump was in 2022 - immediately by 8% compared to 2021.
Prices for imported drugs are steadily rising. For the three quarters of 2022, Osimertinib sales increased by 24% - from 3.8 billion rubles. up to 4.7 billion rubles, and in packages - by only 22% (from 13.8 thousand to 16.8 thousand). Similarly with Axitinib. In money, the volume increased by 4% (from 1.5 billion rubles to 1.6 billion rubles), and in packages - only by 2% (from 13.1 thousand to 13.4 thousand).
There is a risk that some patients will not be able to receive timely care. The only factor that forces foreign companies to lower prices is the loss of monopoly position when competitors appear on the market - biosimilars and generics.
So, according to the results of 3 quarters of 2023, the price of the original imported drug Cabazitaxel (from metastatic castration-resistant prostate cancer) fell by 17%. It is one of the five most popular drugs against oncology. In 2023, Kabazitaxel's sales amounted to 62 million rubles. The drop in value is associated with the entry into the market of 6 domestic generics at once (AxelPharm, Pharmsintez Nord, Veropharm, Farmera, LaraMed and Promomed).
| | Prices for our Russian medicines are much more affordable than imported drugs, which means that more patients will be able to receive the necessary treatment on time, "the press service of Onkotarget said. | |
For 5 years, oncology has been among the top 3 areas of clinical research in Russia. In 2023, drugs against cancer (13%) took 3rd place, losing only to cardiology (17%) and drugs of general therapy (18%).
As of February 2024, in terms of sales, one of the leaders in the field of cardiology is Apixaban (for the treatment and prevention of blood clots and stroke in people with non-valvular atrial fibrillation). From September to December 2023, the first three Russian generics of Apiksaban were registered at once: the companies Biserno, Canonpharma Production and Promomed. Before competitors entered the market in the three quarters of 2023, the average price of imported Apixaban increased by 3%. Sales fell by 12% (from 12.2 billion rubles to 10.6 billion rubles), and the volume of packages - immediately by 15% (from 7.8 million to 6.6 million). The emergence of domestic drugs on the market will turn the tide: increase the necessary production volumes and reduce prices.
In Russia, the leader in the number of clinical trials of drugs has changed
At the end of 2023, 761 clinical trials of drugs were approved in Russia. Domestic pharmaceutical companies are replacing foreign drugs in terms of the number of studies carried out, and European and American organizations are replaced by manufacturers from the SCO and EAEU countries. This is stated in a study by the analytical firm Sciencefiles, the results of which were published in early February 2024.
The report says that in 2023, among domestic companies that received the most approvals in clinical drug trials, the leader changed. If in 2022 the first position was taken by Promomed with 51 projects, then in 2023 the Update company with 45 studies broke out to the top of the rating. In second place, as in 2022, was Pharmsintez - 39 projects, in third - Amedart with 34 studies.
By the end of 2023, the share of clinical trials of foreign sponsors increased: it amounted to 34% among all approved projects (during the year this figure did not exceed 33%). The total number of pharmaceutical manufacturers that initiated clinical trials turned out to be the maximum in 2023:46 companies became sponsors. The leaders in the number of permitted projects are Mylan (India), Velpharm, Valenta and PFC Update (all - Russia). Among the foreign sponsors whose studies were approved by the Ministry of Health of the Russian Federation, representatives of Belarus, Bulgaria, Germany, India, the USA, Turkey, Sweden and South Korea are indicated.
As for drugs, the company was most interested in drugs such as rivaroxoban (cardiovascular drug), apixaban (for venous thromboembolism) and vildagliptin (for type 2 diabetes).[1]
The Ministry of Education and Science allocated 2.5 billion rubles for the renewal of devices in medical scientific institutions
On December 4, 2023, the Ministry of Education and Science of Russia announced that a total of about 200 scientific organizations, institutes and universities will receive grants for updating the instrument base in 2024. 11.56 billion rubles will be allocated for these purposes, of which at least 2.5 billion rubles will go to 42 medical centers and medical scientific institutions.
The documents of the Ministry of Education and Science say that thanks to state support, the technical equipment of organizations performing research and development continues to improve. The book value of equipment (instrument base) used for scientific research for the period from 2019 to 2022 increased by 27.8% - from 462 billion to 590.6 billion rubles. In 2019-2023, the total amount of allocated funds for these needs amounted to 52.9 billion rubles, which made it possible to update the instrument fleet of leading organizations by more than 27% by the beginning of 2023. By the end of 2023, this figure exceeds 40%.
The funds are allocated under the federal project "Development of infrastructure for scientific research and training of personnel" of the national project "Science and Universities." To obtain soils in 2024, organizations need to meet certain requirements. In particular, the share of purchases of Russian equipment should be at least 25% of their total volume, and the indicators of extrabudgetary funds raised to update the instrument base should be at least 10% of the total.
In 2024, the largest grants for research in the medical field will be received by the National Medical Research Center named after V.A. Almazov and the Institute of Bioorganic Chemistry named after M.M. Shemyakin and Yu.A. Ovchinnikov - 243.3 million rubles each. National Medical Research Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakova, Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences and the Federal Research Center for Problems of Chemical Physics and Medical Chemistry of the Russian Academy of Sciences will receive 162.2 million rubles each. For the rest of the medical institutions included in the list, grants in the amount of 10 million to 81.1 million rubles were approved.[2]
The number of clinical trials in Russia involving research organizations has decreased by a third since 2021
According to the data, Ministry of Health in the first 10 months Russia of 2023, 11% fewer clinical trials were carried out than in the same period in 2021. A total of 618 studies were launched between January and October 2023, against 696 the year before. The reduction was mainly due to a decrease in the number of international studies, company representatives shared on November 27, 2023 "Database Flex" with medical that a portal. Zdrav.Expert
In addition, the proportion of research conducted with contract research organizations (CROs) has significantly decreased. If in 2021 KIO accounted for 25% of all studies, then in 2023 - only 20%. In absolute terms, this means a drop from 173 to 123 studies conducted by KIO, that is, by 29%.
Experts explain the reduction in research by the consequences of sanctions and the departure of international pharmaceutical companies from the Russian market. According to their forecasts, in the coming years the situation will only worsen.
| | According to Olga Loginovskaya, Executive Director of Flex Database, such trends indicate a significant shift in the Russian clinical research market: "It is necessary to prevent the quality of research in Russia from falling with the departure of international companies and a decrease in the involvement of professional organizations (KIO) in conducting clinical trials. Now the question is how much Russian pharmaceutical companies and KIO will be able to maintain the same level in the context of budget savings. " | |
In the near future, the Ministry of Health of the Russian Federation plans to launch inspections of medicines.
| | "Currently, a draft Order on pre-registration inspections is being prepared. The essence is that the pharmacovigilance system should function until the moment of obtaining the marketing authorization of the drug and can be checked by the regulator. Post-registration inspections will follow, - said Kirill Vitalievich Gorelov, deputy head of the Department for Organizing State Quality Control of Medical Products of Roszdravnadzor. "A lot of attention will be paid, among other things, to checking quality management systems." | |
The availability of high-quality validated information systems will be the basic condition for the effective functioning of pharmacovigilance systems for marketing authorization holders.
| | "There are many budget quickly made software solutions on the market that can look beautiful, but behave unpredictably in practice," said Olga Loginovskaya, executive director of Flex Database. "As a result, this can give rise to problems in their use, leakage or even loss of data." | |
As she emphasized, one of the indispensable quality guarantors is the use of special computer systems for the management of clinical research and pharmacovigilance. These programs prevent human error, provide self-monitoring processes, which minimize the risk of poor quality and significantly protect clinical research companies and marketing authorization holders from errors, ensure product reputation in the market and greatly facilitate inspections and audits.
How long it will take to restore the market is still unclear. Large international pharmaceutical companies and KIO have practically left the Russian market. Their place is taken by smaller players who, in pursuit of budget savings, cannot always ensure the proper quality of research. In addition, many of them prefer to go without the services of KIO in order to reduce the cost of auditing and monitoring the progress of research. Now, with the imminent start of state inspections, companies that want to remain on the market will have to modify, which means applying special computer programs for pharmacovigilance, clinical research management, quality, budget, training, according to experts from Flex Database.
In general, in their opinion, the regrouping of the Russian clinical research market can be stated. If earlier the key players were international pharmaceutical companies, phase I-III research prevailed, then in 2023 the leadership passed to domestic organizations and the number of bioequivalence studies and post-registration studies significantly increased.
One of the interesting trends in the CT market in the Russian Federation is the liberation of a large number of well-trained, experienced professionals in the field of CT. Competent use of their skills, providing them with interesting, ambitious tasks can serve as a guarantor of high-quality CTs and will prevent the loss of this resource.
Thus, despite the general reduction in the number of clinical trials in 2023, Russian KIOs have the potential to develop and increase expertise in this area, the Flex Database company is convinced.
| | The prospects for further growth of this market segment will largely depend on the ability and desire of domestic self-regulatory organizations to meet high quality standards, to use special computer systems for pharmacovigilance, clinical research management, quality, training and budget in their work, the experts concluded. | |
In Moscow, 57% of all clinical trials of drugs in Russia are carried out
In Moscow, 57% of all clinical trials of drugs in Russia are carried out against 42% in 2022. Such data are given on the official website of the capital's mayor in mid-November 2023.
According to the Deputy Mayor for Social Development of Moscow Anastasia Rakova, Muscovites should be provided with medicines, an ecosystem with a single communication center - the Moscow Center for Innovative Technologies in Healthcare - has been formed in the city for clinical research. When contacting pharmaceutical companies, he helps with access to the entire Moscow medical infrastructure, she noted.
The clinical research support program started in the fall of 2022. Within its framework, pharmaceutical companies that are already conducting or planning to conduct research on the basis of city medical institutions can receive organizational or financial assistance. Before the start of the support program last year, this figure was at 42%, the deputy mayor said.
During the year of the program, 42 applications were received for organizational support measures, eight more - for financial, the remaining two - for both of these measures. Pharmaceutical companies have sought financial support for ten clinical trials. Of these, six received approval from the clinical committee.
Also, since the beginning of the program, about 30 teams working on the basis of leading metropolitan medical organizations have participated in the research. A single digital healthcare platform has significantly increased the recruitment of patients in ongoing research and, as a result, reduced their terms.
As Rakova said, in such therapeutic areas as infectious, rheumatological, oncological, hematological, endocrinological and individual rare diseases, recruitment increased by more than 50%.[3]
Russian pharmaceutical companies have sharply increased the number of clinical trials
Russian pharmaceutical companies have sharply increased the number of clinical trials after foreign manufacturers stopped them. Such data in mid-October 2023 are provided in the Register of Permits for Clinical Trials (RCT).
As Vedomosti writes with reference to the materials of the RCT, from January to early October 2023, R-Farm received 21 permits to conduct clinical trials against seven for the entire 2022. At Geropharm, the number of such tolerances increased year-on-year from 4 to 20, at Pharmstandard - from 5 to 11, and at Generium - from 6 to 8. "Akrikhin" in the first three quarters of 2022 did not receive a single permit, and in January-October 2023 there are already six of them, the newspaper notes.
According to the RCT, in the first 10 months of 2023, not all large pharmaceutical companies increased the number of tests. Thus, Valenta Farm for the specified period received only three permits to conduct research against 10 in 2022. Vertex received one permit, although there were 12 in the first nine months of 2022, the publication said.
In the first half of 2023 Ministry of Health , he issued seven permits for international multicenter clinical trials of drugs to foreign companies and one to the Russian one. Biocad Writes about this "" Kommersant with reference to the Association of Clinical Research Organizations (AOKI), whose calculations the newspaper got acquainted with. The issuance rate is 13.9 times less than a year by year, but in the first half of 2022 the number of such permits also decreased - by 27.5%, to 111.
Foreign pharmaceutical companies, including Novartis, Pfizer, Roche, Sanofi, after February 2022 announced the termination of new studies in Russia and the recruitment of additional patients in the current ones. According to the RCT, Pfizer, MSD, Sanofi, Roche will only investigate their drugs in advanced stages in patients involved in previous phases of trials.[4]
Mishustin allocated 503 million rubles for research in the field of health care
In March 2023, Prime Minister Mikhail Mishustin signed an order on the allocation of about 503 million rubles for research in the field of health care within the framework of the federal project "Medical Science for Humans." According to the press service of the Cabinet, with the help of federal funding, new medical devices will be created, drugs based on cellular technologies and tissue engineering technologies will be developed, and their clinical research will be carried out. This will improve the quality and accessibility of medical care for people.
Work in these areas will be organized at the Lomonosov Moscow State University, as well as in institutions subordinate to the Ministry of Education and Science and the Federal Medical and Biological Agency (FBMA).
The federal project "Medical Science for Humans" provides for the creation of new drugs and medical devices using innovative technologies. The project is included in the list of 42 strategic initiatives for the socio-economic development of Russia, which was developed and approved by the government in October 2021 and includes projects "designed to improve the quality of life of people, ensure sustainability and economic growth."
In accordance with this project, by 2024 it is planned to sharply reduce the cost of producing drugs and medical devices, as well as register at least three test systems for diagnosing cancer.
In addition, in Russia in the coming years, the production of scientific equipment will be established, including those necessary for medical developments. In November 2022, scientists compiled a list of 100 devices with the highest priority for import substitution, and work has already begun on 15 of them by March 2023. It is expected that by 2030 one hundred of the most necessary devices for scientists will already be produced in Russia. More than 2 billion rubles will be invested in their development until 2025.
Government of the Russian Federation Order of March 18, 2023 No. 620-r
2022
"Invitro" took half of the Russian clinical research market
In 2022, the laboratories of the Invitro holding accounted for approximately 47% of the total volume of clinical trials of drugs conducted in Russia, permits for which were provided by the Ministry of Health of the Russian Federation. For comparison, in 2014, Invitro's share in the corresponding segment was 7%. Such figures were released on May 11, 2023.
It is reported that in 2022, approximately 750 multicenter clinical trials were carried out in Russia. At the same time, the Invitro laboratories took part in 349 active projects: the key areas of work were oncological and cardiovascular diseases, neurology, diabetes mellitus and multiple sclerosis.
It is noted that the Invitro holding, which entered the clinical research market as a centralized laboratory in 2003, is working on the basis of seven sites located in Moscow, St. Petersburg, Novosibirsk, Chelyabinsk and Samara, as well as in Kazakhstan and Belarus. In addition to medicines, the company performs clinical studies of medical devices on orders from Russian customers and foreign corporations. In particular, the analysis of products for diagnostics is carried out. As of the beginning of May 2023, the Invitro Clinical Research Department performed work on 280 projects, and another 100 requests for clinical trials were under processing.
In general, as noted, in 2022, the total number of permits issued for clinical trials in Russia decreased by 18.5% compared to 2021. This is due primarily to the current geopolitical situation, due to which many international pharmaceutical companies have stopped operating on the Russian market. In addition, there is a departure from the Russian Federation of contract research organizations.[5]
The first narrow-profile laboratory of pharmaceutical research in Russia opened in Moscow
In June 2022, the Scientific Center for the Examination of Medical Products of the Ministry of Health of Russia was opened at Skolkovo, Russia's first narrow-profile research laboratory for pharmaceutical research (LFI). The area of the institution is 156 square meters. m, there it is planned to annually conduct about 100 studies of drugs at various stages of their life cycle. Read more here.
Mishustin approved benefits for research and development in the field of medicine
In February 2022, Prime Minister Mikhail Mishustin signed a decree expanding the list of types of scientific research and development (R&D), the costs of which can be taken into account to reduce tax payments. Among other things, the document includes a block that includes technologies for the provision of personalized medical services, as well as medical equipment.
As the press service of the Cabinet explains, the costs of research and development included in the list of the Government of the Russian Federation reduce the income tax base using an increasing coefficient of 1.5. They are allowed to be taken into account at a time in the reporting tax period in which they were implemented.
In the field of medicine, weakening will affect the development of devices and services for monitoring and correcting a person's condition, including telemedicine, as well as personal medical assistants, which allow you to automatically track the number of calories, hydration and stress levels. In addition, the R&D tax advantage can be obtained on the costs of developing and applying surgical instrument tracking technology for surgical navigation systems.
The innovation also extends to technologies to increase human health reserves, including the collection, processing of information, the formation of recommendations and their direction to the consumer, as well as the creation of methods of genetic diagnostics in vitro and bioinformatic tools for the interpretation of genetic research data for diagnostic purposes.
The initial list of technologies for R&D was approved by Decree of the Government of the Russian Federation No. 988 of December 24, 2008, it included genomic, cellular technologies, as well as part of personalized medicine technologies.[6]
2021: Budget spending on medical science in Russia reaches 10-year high
In 2021, federal budget expenditures Russia on applied research on the profile health care reached 33.25 billion, rubles which corresponds to 9.6% in the total structure of allocations to civilian science, the share of medical research. This share was the highest in 10 years. Such data are contained in a study by the Institute for Statistical Research and Economics of Knowledge HSE on the actual expenditures of the federal budget for civil science in Russia in comparison with the leading countries of the world. The report was published in late August 2022.
The study presents summarized data since 2011. It follows from them that in 2011 the expenditure on applied research related to health care accounted for only 2.4% of the total budget. Since that moment, this share has constantly grown and in 2017-2018 already reached 5 and 5.9% of the total amount of funds allocated, respectively.
In 2021, compared to the previous year, the amount of allocations for civil science from the federal budget decreased by 2.1% (in constant prices), for applied scientific research - only by 0.5%, and for fundamental research - by 4.9%. The largest increase over the past year is noted in terms of support for research in the field of social policy (+ 49.8%) and housing and communal services (+ 15.6%). In 2020, it was in these areas that there was a significant reduction in funding. In the healthcare sector, on the contrary, a significant increase in allocations in 2020 (+ 52.2%) associated with the COVID-19 pandemic in 2021 was replaced by a decrease (-26.9%).
In 2011, spending on applied research related to health care accounted for just 2.4% of the total budget, according to the study. Since that moment, this share has constantly grown and in 2017-2018 already reached 5% and 5.9% of the total amount of funds allocated, respectively[7]
2020: The number of researchers in medicine in Russia decreased by 13% over 10 years
The number of researchers in medicine in Russia decreased over 10 years (from 2011 to 2020) by 13.2%. At the same time, in 2020, relative to 2019, the number of such specialists increased by 1.2%. Such data in October 2021 were published at the Institute of Statistical Research and Knowledge Economics of the Higher School of Economics.
According to experts, by the end of 2020, the number of specialists employed in the field of scientific research and development fell by 3.2 thousand people compared to 2019 and amounted to 679.3 thousand. This is approximately 1% of the average working population.
The decline in the number of scientists accelerated in 2016, when the authorities cut spending on science after the annexation of Crimea and a recession in the economy. Simultaneously with the reduction of natural science and technical personnel in science, the growth of humanitarian specialists in the field of economics, psychology, history and sociology began. It was 18.3% in the social sciences and 4.2% in the humanities.
The number of researchers with the degree of candidate or doctor of sciences decreased from 109.5 thousand people in 2011 to 99.1 thousand people by the end of 2020. Despite this dynamics, the relative indicators practically did not change: the share of candidates of sciences in the total number of researchers in 2011-2020. remains at the level of 22%, doctors of sciences - 7%.
The bulk of researchers, according to data for 2020, are researchers (51%, or 346.5 thousand people), followed by auxiliary and other personnel (40%), as well as equipment (8.8%).
In 2020, 85.5 thousand employees were admitted to scientific organizations, of which 14 thousand are university graduates (16.4%), as well as employees of other scientific institutions (15.8 thousand people, 18.4%). At the same time, 91.1 thousand people dropped out of these organizations, including 2.8 thousand fell under the reduction.[8]
Notes
- ↑ In 2023, 761 clinical trials of drugs were approved in Russia
- ↑ Minutes of the meeting of the commission on selection of applications of leading organizations performing scientific research and development
- ↑ More than half of all clinical trials of drugs are carried out in Moscow
- ↑ Russian pharmaceutical manufacturers are carried away by clinical trials
- ↑ "Invitro" took half of the Russian KI market in 2022
- ↑ The government has expanded the list of R&D types to reduce the income tax base with an increased coefficient
- ↑ Financing of civil science in Russia and abroad
- ↑ The scale of employment in Russian science
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