Foreign drugmakers expand Russian launches through localization and alternative approvals

Original drug launches recover

Foreign pharmaceutical companies continue to introduce original medicines in Russia despite the withdrawal of most large international manufacturers from new local clinical trials after February 2022. Research by the Inpharma association and DSM Group, reviewed by Kommersant, counted 29 original imported drugs appearing on the Russian market for the first time in 2025. That was 2.4 times the 2022 level.

The annual total fell from 12 new original medicines in 2022 to nine in 2023, before rising to 23 international nonproprietary names, or INNs, in 2024 and 29 in 2025. Oncology accounted for 24.5% of the original medicines launched during 2022–2025. Diabetes treatments represented 13.5%, antiviral products 7% and immunosuppressants 5.6%.

The broader launch data show a different mix. Foreign companies introduced 31 new INNs in 2022 and 37 in 2025, including six localized products. At the same time, their new generic introductions dropped from 100 in 2022 to 48 in 2025. DSM Group also found that products launched in a given year represented about 1% of the Russian pharmaceutical market by value in 2025, down from 1.7% in 2022, which the researchers said may indicate slower financing of innovation.

Companies use trials started before 2022

AstraZeneca registered five new original drugs and two new dosage forms in 2024–2025, according to Ekaterina Yakovleva, the company’s director of drug registration in Russia and Eurasia. It was the only major international company that did not stop local and international studies in Russia, owing to the autonomy of its local business.

Roche introduced two original medicines and obtained six new indications for existing products in 2024–2025. Pfizer’s Russia chief executive, Nikita Ivanov, said the company had launched about 10 innovative medicines and vaccines over five years and registered more than 20 additional dosages and indications. Some launches may be orphan drugs, which can be registered using international trial data without Russian clinical studies, although Inpharma and DSM Group did not calculate their share.

International clinical-trial approvals by Russia’s Health Ministry have remained limited. Their number fell 85% year on year to 18 in 2023, while 22 were approved in 2025. Access to some international platforms, logistics and the rapid shipment of biological samples to laboratories have become more difficult, Inpharma executive director Vadim Kukava told Kommersant.

Alternative registration channels emerge

The remaining pipeline still includes studies authorized before 2022. Pfizer registered Ilreksi, based on elranatamab for multiple myeloma, in July 2026 after receiving trial authorization in 2021. Roche said one of its two recent products also relied on evidence from research begun before 2022; Kommersant identified it as most likely Itovebi, an inavolisib-based targeted oncology drug registered in late 2025.

Companies are also testing mutual recognition under Eurasian Economic Union rules. This permits registration in one member state followed by recognition elsewhere without a separate clinical trial in every country. Roche began a new study in Kazakhstan and plans to seek registration afterward. Kazakhstan’s registry shows that the company obtained approval in 2024 for a Phase III trial of vamikibart for eye diseases.

Another route involves Russian inspections of clinical centers abroad to verify compliance with EAEU good clinical practice rules. International manufacturers began requesting these inspections in 2025. Inspections have taken place at France’s Ipsen and Japan’s Eisai, whose medicine became the first registered through this mechanism in July 2026. Roche plans to use the procedure, while Pfizer has requested an inspection of Phase II research for the breast-cancer medicine tucatinib, sold as Tukysa.

Launch activity expected to hold

Kukava expects the number of new INNs entering Russia to remain stable, citing market data and the plans of Inpharma members. RNC Pharma development director Nikolai Bespalov also sees no decline in new-product activity, arguing that Russia remains attractive to international companies as domestic manufacturers intensify competition. The new approval routes can sustain access, but the reduced market share of recent launches shows that a higher product count does not necessarily translate into stronger commercial penetration.