Pharmaceutical companies from India and China have not yet been able to replace original Western drugs on the Russian market

The hope that pharmaceutical companies from China and India will replace modern drugs from Western manufacturers on the Russian market has not yet been justified. The number of clinical studies they conduct in the Russian Federation is rare and mostly concerns generics. But Russian companies are also actively introducing the latter to the market. It is thanks to this that the number of trials of new drugs approved by the Ministry of Health in 2023 increased by almost 3% after a fall of 20% in 2022. Meanwhile, the problem with original medicines remains, experts emphasize.

At the end of 2023, the Ministry of Health approved 761 clinical trials (CTs) of new drugs and medical devices, which is 2.8% more year-on-year, Kommersant calculated based on the CT register. For comparison: at the end of 2022, a decrease of 18.5% was recorded. In the past year, growth was achieved due to a 14% year-on-year increase in the number of tests by Russian companies. Local drugmakers accounted for 78.7% of all trials, up from 45.7% in 2022.

The number of international multicenter studies at Russian sites in 2023 decreased almost eightfold, to 16. At the end of 2022, according to the Association of Clinical Research Organizations (AOKI), the decrease was threefold.

After the outbreak of the military conflict between the Russian Federation and Ukraine, large international pharmaceutical companies, including Pfizer, AbbVie, Novartis, Sanofi, stated that they would not begin new clinical trials in Russia. In 2022, these companies were still issued permits, the documents for which were submitted before February 24, but in fact, some of the tests were not carried out. And in 2023, Janssen, Roche, Sanofi received single permits for extended studies – for already registered drugs. Among international companies, only the American Agenus, the Chinese Ascentage Pharma, the Korean Protox, and the Indian Aurobindo Pharma have started full-fledged new trials.

Russian pharmaceutical companies, for example, Biocad, Generium, R-Pharm, Grotex, Pharmasintez, have also announced international studies. But Kommersant was able to find only two studies of Biocad, also conducted in Belarus. The company told Kommersant that it is also conducting research in India, Pakistan, the countries of the Middle East and North Africa and Europe, doubling such trials in total over three years to 41. Pharmasyntez and R-Pharma declined to comment . The remaining manufacturers did not respond to Kommersant’s request.

After the refusal of large international players from new research, it was expected that pharmaceutical companies from India and China would show interest in the Russian market, says Svetlana Zavidova, executive director of AOKI. At the same time, according to her, only Chinese manufacturers pay attention to the development of original drugs, but they cannot replace international companies.

So far, the bet on China has not been justified: Chinese manufacturers have begun only two tests in the Russian Federation, compared to five a year earlier. The Russian market may be potentially interesting to players from China, but in the future for 5-10 years, says Nikolai Bespalov, development director at RNC Pharma. The Russian market has already developed, international players continue to supply drugs and can return with research, so Chinese companies are in no hurry to expand in Russia, says Igor Utyashev, director of the clinical research department of Medscan Group.

The number of studies initiated by companies from India has doubled, to 62. Indian players have the opportunity to expand their presence, but, according to Nikolay Bespalov, this will most likely be in the format of partnership with Russian companies. Players from Turkey and Iran also began new studies in 2023, as follows from the CI registry. But these companies can offer generics, for which, according to Mr. Bespalov, there is already quite tough competition on the Russian market.

Polina Gritsenko