Drug therapy for diabetes is becoming more accessible

Over the past 20 years, the number of people with diabetes in Russia has more than doubled. The issue of therapy accessibility is very acute. The company Nizhpharm is contributing to the treatment of the disease by announcing the localization of production of Incretin, a drug included in the List of Essential and Vital Medicines, for the treatment of type 2 diabetes . GxP News reports on how the production line was launched and what will change in drug supply.

In 2025, about 5.8 million Russians had an official diagnosis of diabetes, according to experts from the National Medical Research Center for Endocrinology named after Academician I.I. Dedov; however, experts believe the real number could reach 12 million people. Specialists emphasize the epidemic nature of the disease.

During the implementation of the national project “Combating Diabetes ,” which began in 2023, the country’s endocrinology service was reorganized. Endocrinology centers have been equipped using the federal budget and are now open in all regions of Russia.

“Timely detection of diabetes and the correct prescription of innovative drugs are what Russian patients have today,” notes Natalia Mokrysheva, Director of the National Medical Research Center for Endocrinology named after Academician I.I. Dedov. “The development of the domestic pharmaceutical industry and support from the state are also among the achievements of the national project.”

Currently, about 165 drugs for the treatment of diabetes are registered in Russia, but this does not mean that the problems with drug supply have been completely resolved.

The process of localizing the drug Incretin will improve the accessibility of treatment for type 2 diabetes for patients, according to Dmitry Isachenko, General Director of the Nizhpharm group of companies.

“By 2030, we plan to produce 2 million packages per year, which means that more than 150,000 people will receive therapy on time and regularly. But this figure is not the limit; our production site is ready to respond to the state’s needs in terms of providing for patients suffering from type 2 diabetes ,” Isachenko emphasized during the ceremonial launch of the production line.

The process of technology transfer and localization of the full-cycle production of the drug is a complex, phased process that requires staff training and compliance with all GMP rules. First, it involves the purchase and launch of new equipment, then the transfer of production technology, methods for controlling raw materials and finished products, and process automation.

“Since the tablet is two-layer, production includes the granulation of two different mixtures. The confirmation that the site has mastered the work is the consistent quality of three validation batches. But even after that, the quality control laboratory checks each batch produced,” Dmitry Isachenko, General Director of Nizhpharm Group, told guests at the plant in Obninsk. “Control is carried out at all stages of production: we check each batch of raw materials, packaging, and auxiliary materials, conduct sampling and in-process control at all critical points, carry out regular monitoring of the cleanliness of equipment and room surfaces, air, and the hands and clothing of personnel, and control water quality. Such close attention gives confidence that the patient receives a high-quality domestic drug.”

The drug is a combination of two hypoglycemic agents: alogliptin (an inhibitor of the enzyme dipeptidyl peptidase-4) and pioglitazone (a representative of the thiazolidinedione class). According to Natalia Mokrysheva, such innovative solutions improve compliance, that is, patient adherence to treatment, precisely because it is no longer a handful of tablets, but just one.

The localized drug has been included in the List of Essential and Vital Medicines since March 2025 and participates in preferential drug supply programs. “Currently, in 83 regions of the Russian Federation, it is included in territorial preferential drug supply programs, and 69 regions actively use it to treat patients with type 2 diabetes . Every month, more than 8 thousand patients receive the drug for free under preferential drug supply,” reported Dmitry Isachenko.

Most diabetes patients receive benefits if they have disability status. But given its current prevalence, the disease has moved into the category of high socio-economic significance. The target group includes more than 105 thousand Russians under the age of 60 with cardiovascular and renal pathologies who do not have a disability.

“It is necessary to emphasize that diabetes is among the challenges undermining the country’s human resources potential. This is reflected in the reduction of life expectancy for the working-age population and the loss of highly qualified personnel from the economy,” stressed Anton Danilov-Danilyan, Deputy Chairman of Delovaya Rossiya.

And although there is currently no way to cure either type 1 or type 2 diabetes, innovative drugs provide the opportunity to achieve prolonged remission and maintain quality of life.