Foreign pharmaceutical companies have practically ceased to receive permits to conduct clinical trials of new original drugs
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Foreign pharmaceutical companies have practically ceased to receive permissions to conduct clinical trials (CTs) of new original drugs: in the first half of 2023, only seven were issued. Russian developers, who are increasing the number of generic trials in an attempt to prevent a possible drug shortage, cannot yet compensate for the departure of international players. Experts believe that there may be workarounds for the access of new foreign drugs to the Russian market.
In January-June, the Ministry of Health issued only seven permits for international multicenter clinical trials to foreign companies and one more to the Russian Biocad, follows from the calculations of the Association of Clinical Trial Organizations (AOKI), which Kommersant got acquainted with.
This is 13.9 times less year-on-year, although in the first half of 2022 the number of such permits also decreased – by 27.5%, to 111.
Most of this type of research precedes the introduction of foreign originator drugs to the market. Foreign companies are required to conduct tests on Russian patients for its subsequent registration. After the outbreak of hostilities in Ukraine, foreign pharmaceutical companies, including Novartis, Pfizer, Roche, Sanofi, announced the cessation of new studies in Russia and the recruitment of additional patients in the current ones.
According to the clinical trial registry, Pfizer, MSD, Sanofi, Roche will only conduct late-stage trials of their drugs in patients who participated in previous phase trials. Sanofi confirmed this information.
The only company that received permission to test the early phase is the American AbbVie.
According to ACTO, the company submitted an application even before the restrictions on work in Russia, but in fact will not carry it out. AbbVie, Pfizer, MSD and Roche did not respond to Kommersant’s request.
According to ACTO, only the small American Agenus announced the only two full-fledged international studies. The company did not announce restrictions on work in Russia.
In total, the number of clinical trials approved in January-June decreased by 20%, to 340, but the number of trials of generics by Russian companies increased by 33.9% year-on-year, to 229. Now, in the structure of permits issued, such trials account for 67.4%, then as a year ago – 40.2%. There is a noticeable trend in the Russian market for the rapid withdrawal of generics for which there is already a shortage or it may arise in the near future, says Natalya Rabinovich, CEO of the contract research company (CRO) IPharma.
The number of local studies of original drugs and biosimilars by Russian pharmaceutical companies fell by 43% to 51.
Biocad is currently investigating six such drugs, the development of which began five years ago, and now 12 more original molecules are in early development, the company said. The development of original medicines by Russian companies is not enough to meet the demand in the domestic market, they say in CRO “OST Rus”. According to Natalya Rabinovich, there are potentially interesting molecules in the portfolios of small companies, but they cannot conduct clinical trials due to lack of funding.
If Western pharmaceutical companies do not resume conducting clinical trials in Russia, there are other ways to enter the Russian market of breakthrough therapy, Nikolai Bespalov, RNC Pharma Development Director, believes. This, according to him, is the use of unregistered drugs or the recognition in Russia of the results of tests conducted abroad. The possibility of recognizing foreign research was discussed at the Ministry of Health back in March. On August 3, the Ministry of Health did not respond to Kommersant’s request.
At the same time, foreign companies can test drugs in one of the EAEU countries for subsequent registration of drugs in the Russian Federation according to the rules of the union, says Svetlana Zavidova, executive director of ACTO. Mr. Bespalov expects the arrival of players from Asian countries, including China, where medical technologies are actively developing.
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