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GEROPHARM Relaunched Ozempic® in Russia, Under the Name of Semavic®

6 October 2023

GEROPHARM has its medicinal product Semavic® authorised in Russia. It will replace Ozempic® that is no longer available in Russia. Novo Nordisk of Denmark stopped shipping Ozempic® this year, despite it being one of the “life-saving” medicinal products. GEROPHARM is able to cover the domestic need for this medicine, for which the company has the necessary manufacturing facilities.

Semaglutide-based products such as Semavic® are among the most promising antidiabetic drugs. They are mostly used in patients with type 2 diabetes mellitus.

Recently, there were only two semaglutide-based products in the Russian market: tablets Rybelsus® and injectable Ozempic® from Novo Nordisk, Denmark. This manufacturer announced it would stop supplying these products to Russia in 2024, but the market started experiencing their shortage long before.

Russian company GEROPHARM made a decision to launch its own, domestically produced, analogue of Ozempic® — Semavic® — in order to fully cover the need of the healthcare system for this medicinal product in the same presentations. It is essential, as the product has to be used continuously over a long period of time.

In August this year, the company successfully completed a clinical study, whose findings enabled experts to recognise Semavic® and Ozempic® bioequivalent and equally safe. On 6 October, the product was granted marketing authorisation and, once the procedure of mandatory licensing is complete, it will be launched in the market. The license is required as Novo Nordisk still holds the patent for the molecule.

GEROPHARM will be manufacturing the new product at its own plant in the Moscow region. The plant has facilities to produce lyophilised forms, solutions and suspensions in vials, cartridges, and pen injectors. The practices adopted at the plant are in line with the high national and international standards of GMP.

“Presently, Russian patients who need medicines containing semaglutide have to either switch to other, less efficacious -glutides, or use unofficial channels to buy the medicines, previously available to them under the benefits scheme, at a higher price and with no guarantee of quality and safety. Domestic production of Semavic® is a major step forward in the pharmaceutical import phaseout. This production will fully cover the need of our healthcare system for this medicinal product and ensure the patients’ safety,” Petr Rodionov, General Director of GEROPHARM says.

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