Glucose goes to analog level

Russian pharmaceutical companies are striving to occupy the niche of the drug for controlling glucose levels Ozempic, the manufacturer of which, the Danish Novo Nordisk, is stopping supplies to the Russian market. Following Geropharm and Promomed, PSK Pharma begins work on an analogue of the drug. Each subsequent generic will have to compete with the previous ones in price, experts point out.

In October, PSK Pharma received permission to study the bioequivalence of SMGS and LRGS drugs in the field of endocrinology, Kommersant found in the clinical trials registry. Their dosages (1.34 and 6 mg/ml) are the same as those of the Danish Novo Nordisk glucose control drugs semaglutide and liraglutide. Semaglutide in the Russian Federation is known under the brands “Ozempic” and “Rebelsas”, liraglutide – “Saxenda” and “Victoza”. A Kommersant source on the market confirmed that PSK Pharma plans to create analogues of semaglutide and liraglutide. PSK Pharma CEO Evgenia Shapiro declined to comment.

Semaglutide and liraglutide are used in patients with type 2 diabetes to control glucose levels, and liraglutide is also registered for weight management. For this indication, Wegovy based on Novo Nordisk semaglutide is also used in the USA, EU and other countries. This drug is not registered in the Russian Federation, but has been used against obesity off-label. Globally, Wegovy has proven to be so popular among those losing weight that Novo Nordisk’s production capabilities cannot keep up with the growth in demand, media reported.

Novo Nordisk plans to stop supplies of Ozempic and Rebelsas to the Russian Federation until the end of 2023. Ozempic began to disappear from pharmacies in the spring, remaining in the state segment. According to DSM Group, sales of semaglutide in pharmacies in January-September decreased year-on-year by 31.9%, to 1.75 billion rubles, and of liraglutide by 50.4%, to 1.1 billion rubles. According to Headway Company, government purchases of semaglutide during this period increased by 2.9%, to 468.3 million rubles.

The first analogues of semaglutide were registered in October of this year by Geropharm (Semavik) and Promomed (Quincenta). Promomed also released liraglutide under the brands Enligria and Quinliro. The patent protection for liraglutide in the Russian Federation has expired, but semaglutide is protected until 2035. “Geropharm” applied to the Russian government with a request for a compulsory license, the company’s general director Pyotr Rodionov said at the Biotechmed forum in October. The Ministry of Industry and Trade told Kommersant that the departments collect and analyze information to make a decision, including the need for the drug and the impossibility of replacing it. They added that they are also analyzing the possibility of obtaining “on reasonable commercial terms” the right to produce the Novo Nordisk drug. Novo Nordisk declined to comment. Promomed told Kommersant that they did not apply for a compulsory license.

DSM Group CEO Sergei Shulyak says that manufacturers are trying to fill the niche of Ozempic and Saxenda, as consumers will strive to buy the drugs that will appear first. It is also important for companies to get into the government procurement segment, where purchases are usually carried out several months in advance, he adds. In addition, Mr. Shulyak notes, each subsequent generic will have to compete with the previous ones in price.

The regions have already begun to conclude contracts for the purchase of Semavik from Geropharm. In the Samara region, the BF Trading House pledged to supply 15 packages of medicine to the State Public Institution Samarafarmatsiya in January 2024, according to data from the government procurement portal. In the Pskov and Kaliningrad regions, contracts for Semavik are being signed. Aleksey Fedorov, an expert at the All-Russian Patients’ Union, says that it is impossible to take into account intellectual property issues at the stage of concluding a contract.

Polina Gritsenko