Two Russian pharmaceutical companies will be able to produce generic alternatives to Ozempiс without the consent of the patent owner — Danish Novo Nordisk.
The Russian government has granted two Russian pharmaceutical companies — Geropharm and Promomed — permission to produce a drug with the active ingredient semaglutide without the consent of the patent owner, the Danish Novo Nordisk, according to the government order.
Novo Nordisk has a valid patent for semaglutide until 2035. It is part of its drug Ozempic, which is popular as a treatment for type 2 diabetes (when a person's pancreas does not produce enough glucose-disposing insulin) and is also used for weight loss. Novo Nordisk notified Russian authorities that it would stop supplying Ozempiс in December 2023.
Geropharm has obtained a compulsory license for the diabetes drug Semavik, which is an Ozempic analogue. The company will be able to produce it for a year without the consent of the patent owner.
Semavik (semaglutide) is included in the list of vital and essential drugs and is available to patients with diabetes at a discount, reported in Geropharm. The list does not specify the drug itself, but its active ingredient.
To legally obtain the rights to produce Semavik, the company applied to Novo Nordisk with letters to conclude a license agreement for the use of patents. Having received no response, Geropharm appealed to the Russian government for a decision on a compulsory license, the company recalled. It noted that the compulsory license transfer for the production of innovative drugs is acceptable against the background of withdrawal of foreign pharmaceutical companies or individual drugs from the Russian market.
Semavik is scheduled to be delivered to Russian pharmacies this year, the first batch will amount to about 250-300 thousand packages. The company will produce the drug at its own plant in Russia. Swiss company Ypsomed was chosen as the supplier of syringe pens. The price of a pack of Semavik agreed by the Russian Ministry of Health and FAS of Russia is RUR 4,279.5 excluding VAT, which is 26% lower than the approved price of the original drug.
Promomed developed the drug Quincenta containing semaglutide. It received registration on October 17. The company introduced it into circulation in late November, before obtaining the license.
