Russian Government Extends Compulsory Licenses for Three PSK Pharma Drug Products Until 2026

In December this year, the Government of the Russian Federation extended permits allowing PSK Pharma to manufacture medicines containing the INNs semaglutide and tedizolid without the consent of the patent holders. As a result, domestically produced medicines continue to improve access to modern therapies.

PSK Pharma’s product portfolio includes two medicines containing semaglutide. Insudive is indicated for the treatment of type 2 diabetes mellitus to improve glycemic control, while Insudive Slim promotes weight loss in patients with obesity when used in combination with diet and physical activity.

Evgenia Shapiro, General Director of PSK Pharma,commented:

After the originator product left the domestic market, patients were unable to receive the required volumes of semaglutide. We are grateful to the Government of the Russian Federation for the trust placed in us - thanks to the extension of the compulsory license, our company will continue supplying this vital medicine to the market.

Demand for injectable drugs containing semaglutide is steadily growing due to their high efficacy and ease of use. Physicians are increasingly choosing this therapy, primarily for patients with type 2 diabetes who are eligible to receive it under preferential reimbursement programs. At the same time, we are seeing growing demand in pharmacies, as many patients purchase these products independently based on medical prescriptions.

PSK Pharma plans its production volumes based on actual demand from both the public sector and the retail market. Our manufacturing capacity allows us to fully meet the country’s demand for drug products containing semaglutide.”

At the same time, the one-year extension of the compulsory license by the Russian Government enables PSK Pharma to continue manufacturing the antibiotic Tedizolid PSK without the consent of foreign patent holders, ensuring continued treatment options for skin infections.

All three medicines are included in the List of Vital and Essential Medicines (EML).