Translated material
The authorities allowed the production of a new analogue of Ozempic
A third generic version of the anti-diabetes and weight loss drug Ozempic will appear in Russia. The government gave the Pharma company the right to produce a new analogue of the drug from the Danish Novo Nordisk, bypassing the current patent protection, Kommersant reported . The reason was the cessation of supplies of the original Ozempic and the shortage of generics available on the market.
A government source explained the desire to circumvent the patent requirements as “an extreme necessity,” the newspaper writes. Previously, Geropharm and Promomed received permission to produce their generics with a similar formulation. Their analogues called “Semavik” and “Quincenta” have sold a total of about a million packages worth five billion rubles since the beginning of the year, the newspaper writes.
Generics are made based on the active ingredient semaglutide, commonly used in the treatment of diabetes. The government issued an order citing Article No. 1360 of the Civil Code, explaining the need to circumvent existing patent rights “to protect the life and health of citizens,” a source in the Cabinet of Ministers told Kommersant.
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Novo Nordisk's patent is valid until 2025. The Danish company notified Roszdravnadzor that it will stop supplying Ozempic to Russia in 2023. The head of the patent practice of the Patentus bureau, Alexey Mikhailov, told Kommersant that due to leaving the market, it will be difficult for the patent owner to explain that now “his rights have somehow been violated.”
In fact, Ozempic was sold in Russia in 2024, the publication cited data from the DSM Group. However, sales were “in much smaller volumes”: from January to September, 29.6 thousand packages were sold for 469 million rubles - approximately two and a half times less than in the same months last year.
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Sales of Russian generics increased from the beginning of the year to October. Semavik has about two-thirds (up to 685.8 thousand packages), Quincenta has about a quarter (up to 275.3 thousand), according to DSM Group figures. The new analogue, from the Pharma company, has already entered the market, but has not yet reached retail, RNC Pharma analysts told the newspaper.
Medicines for diabetes and weight loss have become some of the most popular in Russia due to the growing number of patients, explained the National Medical Research Center of Endocrinology. According to the director of the institute, Natalya Mokrysheva, about 50 million Russians suffer from obesity, of which five million are diagnosed with diabetes.
In October, it became known that there was a shortage in pharmacies of the most popular Russian generic Ozempic, the drug Semavik.
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