All generics are worn out – Newspaper Kommersant No. 17 (7462) dated 01/31/2023

In Russia, clinical trials of drugs are being reduced: in 2022, the Ministry of Health issued 18.5% fewer permits than a year earlier. The fall was the result of the massive refusal of foreign companies from research in the country, although medicines and medical devices were not sanctioned. A 21% increase in trials by local manufacturers could not compensate for the decline, and it was provided mainly by generics. In the future, this may lead to a decrease in the market share of innovative drugs – the most effective in the treatment of cancer, including cancer, doctors warn.

As follows from the data of the Vademecum analytical center available to Kommersant, in 2022 the Ministry of Health issued 740 permits to conduct clinical trials of drugs, which is 18.5% less year on year. Most of them are Russian companies — 526 studies, or 71%. They increased testing by 21%. Foreign manufacturers have more than halved research – they received 214 permits against 493 in 2021.

These data are similar to the calculations of the Association of Clinical Research Organizations (ACTO), and the estimates were confirmed by the Ministry of Health. They reported that in 2022, permits were issued for 740 clinical trials, of which 18.3% were foreign companies, while a year earlier – 908, of which 40.3% were international studies.

The reduction in the share of Western companies occurred against the backdrop of military operations of the Russian Federation in Ukraine. Many large international manufacturers, including Roche, GSK, Novartis, Pfizer, have stopped new clinical trials in Russia and the enrollment of patients in the current ones. Roche and GSK clarified to Kommersant that the studies started before March 2022 are ongoing. Novartis, Pfizer, Sanofi, AstraZeneca did not respond to Kommersant’s requests.

The refusal of Western concerns from research in the Russian Federation worries the authorities, and the head of the Ministry of Industry and Trade at a meeting with Vladimir Putin on January 24 emphasized the growth of Russian tests. “In 2022, the number of studies by pharmaceutical manufacturers in the Russian Federation increased by a third, they registered 130 new drugs,” he said. The growth of local production of drugs, including innovative ones, is included in the Pharma-2020 strategy, extended until 2024. However, according to the executive director of ACTO Svetlana Zavidova, in 2022, most of the trials were for generics. The launch of non-original drugs on the market takes about nine months, and innovative drugs – up to ten years, the expert explains.

According to Ms. Zavidova, the reduction in the number of studies in the Russian Federation by international companies will lead to a decrease in the market share of innovative drugs in the future. In her opinion, the range of medicines in pharmacies and clinics will “slide more and more towards generics.”

Russian companies are really focused on non-original drugs. Of the 526 approvals it issued in 2022, only 168 (32%) are not related to generic research, according to Vademecum. The leaders in their number are Biocad (14 permits), Microgen (13), Promomed (12) and R-Pharm (10).

Biocad notes that in 2022 they increased the number of studies from 26 to 37, most of them on innovative drugs for the treatment of oncological and autoimmune diseases. R-Pharm talks about a threefold increase in research, recognizing the predominance of generics in them. The company promises to expand testing in the field of oncology.

The ongoing research on cancer drugs is really not enough, doctors interviewed by Kommersant say. Their total number has dropped from 187 in 2021 to 107 in 2022, according to Vademecum. Head of the Department of Interdisciplinary Oncology, NMIC DGOI named after A.I. Dmitry Rogachev, Nikolai Zhukov notes that previously most of these trials were conducted by foreign companies, which allowed the Russian patients participating in them to receive treatment with effective innovative drugs long before they appeared in clinical practice. According to Russian legislation, even those new medicines that are being studied in the world are now inaccessible to Russians, Mr. Zhukov adds. According to him, generics are “the day before yesterday and are created on the basis of drugs that have lost patent protection after 15-20 years.”

Contract research organizations (CROs) conducting clinical trials for pharmaceutical companies confirm that their portfolio has shifted towards Russian manufacturers. IPharma Business Development Director Anna Makarenko says that now these clients account for 80%, and foreign manufacturers now include companies from the EAEU, India and Serbia. OST Rus also notes an increase in requests for research on generics from Russian companies. Some CROs that worked in Russia only with foreign customers are forced to leave the market, adds Svetlana Zavidova. According to her, this is what Medpace and Dokumeds did.

The loss of the Russian market also created problems for large international companies, Dmitry Sharov, general director of OST Rus, believes. According to him, Russia was among the top three leading countries in recruiting patients for research. But, Svetlana Zavidova believes, “until hostilities end, there is no need to talk about the revival of international studies in the country.”

Olga August, Natalia Kostarnova