The first analogue of a drug for glucose control has been registered in Russia

The first analogue of the popular drug for controlling glucose levels, Ozempic, has been registered in Russia, which the Danish Novo Nordisk is withdrawing from the local market. Geropharm plans to produce the medicine under the Semavik brand. But a compulsory license will be required for sale, since Ozempic is protected by a patent until 2035.

The large drug manufacturer Geropharm has registered the glucose-lowering drug semaglutide under the name Semavik, the company told Kommersant. The Ministry of Health issued a registration certificate for the drug on October 6, as follows from the data of the state register of medicines.

The original semaglutide – Ozempic from the Danish Novo Nordisk – will no longer be supplied to Russia by the end of this year. The company notified Roszdravnadzor about this in November 2022, wrote RBC. A Vademecum later reported that since the spring of this year, Ozempic has been sold only at a discount and is not sold through pharmacies.

Semaglutide mimics a hormone that regulates glucose levels, including causing a feeling of fullness.

The drug is used to treat type 2 diabetes mellitus with insulin deficiency, and in the USA, EU and other countries it is also used against obesity. In Russia, Novo Nordisk sold semaglutide in two forms – injectable (Ozempic) and tablets (Rebelsas). Both products were sold only for antidiabetic indications.

In 2022, Ozempic sales worldwide increased by 77%, to DKK 59.75 billion (RUB 825.3 billion), Novo Nordisk reports. In Russia, according to DSM Group, in the first eight months of 2023, semaglutide was sold in pharmacies for 2.05 billion rubles.

Semaglutide is included in the list of vital drugs in Russia, its price is regulated. The maximum registered price for Ozempic Novo Nordisk is set at 5.8 thousand rubles. per dose required once a week. Geropharm also announced a maximum price of 6 thousand rubles, the company told Kommersant.

Geropharm says that they offered Novo Nordisk to start producing Ozempic at their facilities, but did not receive a response.

Novo Nordisk declined to comment. “Semavik” is planned to be produced at a plant in Obolensk based on the Chinese ZPC substance, they say in “Geropharm”. They added that they are also working to ensure the production of the substance at their own facilities.

But Geropharm cannot yet put Semavik into circulation: the patent for the original Ozempic in the Russian Federation is valid until 2035. Geropharm expects to receive a compulsory license “in the near future,” says the company’s general director and co-owner Pyotr Rodionov. The Civil Code allows the issuance of a compulsory license in cases of extreme necessity related to ensuring the defense and security of the state, protecting the life and health of citizens. In Russia, one such case is known so far: Pharmasyntez received a compulsory license for remdesivir for the treatment of COVID-19. The owner of the original drug, the American Gilead Sciences, challenged this decision in the Supreme Court, but lost.

The Ministry of Industry and Trade told Kommersant that the mechanism for issuing a compulsory license “requires verified application.”

It is necessary to pay attention to the need for the medicine, the impossibility of replacement, the fact of registration and other factors, the ministry points out. They added that if they receive all the necessary supporting materials from Geropharm, then together with the interested departments they will consider them and send the position to the government.

Geropharm is not the only Russian company vying to produce a replacement for Ozempic. Promomed said that they had submitted a dossier for registration of an analogue of semaglutide. And in September, Promomed registered a generic version of another Novo Nordisk drug, liraglutide, which is used for weight loss.

Polina Gritsenko