The state and regional authorities in Russia are actively supporting pharmaceutical developers in conducting clinical trials. One of the largest regional programs operates in Moscow, which has helped 16 new drugs complete all testing stages and enter the market over the past three years. These include original domestic drugs, new vaccines, and biosimilars.
Moscow’s Leading Role
GxP News found that Moscow has traditionally led other Russian regions in clinical research, serving as the central hub for a significant share of both domestic and international trials.
In the fall of 2022, the Moscow government launched a Comprehensive Clinical Research Support Program, creating a unique infrastructure that offers comprehensive assistance to companies developing vital and innovative drugs. The support includes both organizational and financial assistance in conducting clinical trials.
Mariia Kareva, Director of the Clinical Research Department at the Moscow Center for Innovative Technologies in Healthcare, told GxP News that more than 20 pharmaceutical companies and federal scientific institutions have sought support for over 130 clinical trials since the program began.
“As a result, to date, 16 new drugs have successfully completed all necessary tests and received registration certificates, including six original domestic drugs, three new vaccines, and seven biosimilars, which are important for import substitution,” Kareva said.
Anastasia Rakova, Deputy Mayor of Moscow for Social Development, previously noted that support has been provided for drugs treating conditions such as ankylosing spondylitis, melanoma, lung and cervical cancer, multiple sclerosis, and other serious diseases.
The Moscow program offers pharmaceutical companies an assessment of the feasibility of conducting research in city medical organizations, consulting on protocol development, administrative support, and assistance in selecting both medical institutions and potential trial participants.
Developers of drugs deemed important for the capital’s healthcare can also receive financial support, with reimbursement of up to 50% of the costs for Phase III clinical trials conducted in the city’s medical organizations. According to Kareva, more than 20 studies have already received such support.
Dramatic changes in the market
According to the Association of Clinical Research Organizations (ACTO), major international sponsors—including MSD, Novartis, Pfizer, Eli Lilly, and AbbVie—began exiting the Russian market in 2022. This prompted domestic manufacturers and the government to seek ways to replace these drugs.
The share of international multicenter clinical trials (MCTs) fell from 40% in 2021 to 2.4% in 2023 following the withdrawal of foreign sponsors. During this period, domestic players began compensating for the market loss.
Although the number of bioequivalence studies for generics from Russian sponsors started growing in 2020, the peak activity occurred in 2022–2023. Aafter foreign companies stopped the international multicenter clinical trials, this segment became the largest in Russia, accounting for 62% of all types of research last year.
However, by the end of 2024, the number of generic drugs declined by more than a quarter (27.5%). Experts attributed this to market oversaturation with generic versions of Western blockbusters and urged the domestic pharmaceutical industry to transition to an innovative development path.
A new phase in this transition began with the launch of the national project “New Technologies for Saving Health.” Russian Deputy Prime Minister Tatyana Golikova recently announced that, in its first stage (2025–2027), the state will support clinical trials of nine original medicines for cardiovascular diseases, cancer, and other disorders.
Most often, assistance is provided in conducting phase III trials. The government is also developing measures to assist companies at the product launch stage, including “payment for success” mechanisms and tax preferences, according to Ekaterina Priezzheva, Deputy Head of the Russian Ministry of Industry and Trade.
“Everything suggests that in Russia, the priority is gradually becoming not just replacing obsolete medicines, but creating a sustainable pharmaceutical development system based on national priorities and clinical expertise,” said Mariia Kareva.
She added that the development of artificial intelligence, support for developers, and the expansion of research competencies are contributing to the long-term growth of the industry, ensuring continuous scientific and technological progress in the interest of national health and access to innovative drugs.