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January 17, 2020

GEROPHARM answered questions about Russian insulin

On January 16, 2019 at the TASS site in Moscow, an open dialogue between business, government, researchers and patients diagnosed with diabetes took place as part of the event "The main thing about Russian insulin in questions and answers".

In summer 2019, GEROPHARM received registration certificates for biosymilars of ultra-short duration insulin analogues, combination of short and medium duration and long duration insulin analogues - RinLiz®, RinLiz® Mix 25 and RinGlar®.

In September 2019, these drugs took part in the public procurement procedure for the first time and were delivered to many regions as a result of tenders for preferential coverage of citizens.

Transition to insulin biosymilars raises many questions, doubts, and creates a lot of myths and distortions of facts.

During the event, representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the company GEROPHARM and the Federal State Budgetary Institution "V.A.Almazov NMIC" of the Ministry of Health of the Russian Federation touched upon current topics and answered urgent questions related to import substitution in the pharmaceutical industry, admission of drugs to the market, control of efficiency and safety of drugs circulating on the territory of the Russian Federation by the state, including biosymilars of insulin analogues produced by GEROPHARM - their clinic.

A.V. Alekhin, Director of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation: "Creation by the domestic pharmaceutical industry of such complex technologies as in-house production of full cycle insulin inside the country is an example of successful implementation of the state program PHARMAMED-2020. This is a great contribution not only to ensuring drug safety in the country, but also to the development of the state as a whole. It is the creation of infrastructure, new jobs and applied science. The appearance on the market of biosymilars that meet all the requirements is one more step towards creating our own innovative drugs. And entering the export market is the best confirmation of the quality of drugs".

E.A. Maximkina, Director of the Department of Medicinal Supply and Regulation of Medical Devices Circulation of the Ministry of Health of the Russian Federation: "Today Russia has created such a system of admission of drugs to the market that meets the most modern world requirements and allows to be confident in the efficiency and safety of drugs, both foreign and Russian production. Purchases under the international non-proprietary name allow to provide more patients with vitally important medicines. At the same time, the patient always has a choice - in the presence of medical conditions (individual intolerance, for life reasons) by the decision of the medical commission is appointed and subsequent purchase in accordance with the Law on the contractual system of a specific drug under the trade name for the needs of this patient.

GEROPHARM representatives told the meeting participants that before the registration of biosymilars of insulin analogues the company conducted a set of preclinical and clinical trials that meet both the requirements of the Russian Federation and international recommendations on biosymilar development. They were aimed at confirming the effectiveness and safety of the drug.

GEROPHARM research has successfully passed independent audits and the results have been submitted to the Ministry of Health of the Russian Federation.

P.P. Rodionov, General Director of GEROPHARM: "Since 2013 GEROPHARM human gene-engineered insulin has been widely used in the therapeutic practice, since 2016 the company has been a leader in this segment, in 2019 we received registration certificates for biosymilars of insulin analogues. We have long been in the market and continue to develop it, we have great respect for patients who use our products. We control the efficacy and safety of our medicines from the development stage to the finished product. GEROPHARM looks at the issue of diabetes comprehensively and we are not going to rest on our laurels by expanding our expertise, competence, product portfolio and export. Our next step, which allows us to count on a high level of research, is to enter the markets of European countries. First of all - Germany, France, Spain and Italy".

Special attention during the discussion was paid to the issue of using biosymilars analogues of insulin in children.

In this case, based on the specifics of the product, as well as in accordance with Russian legislation and international requirements (EMA), studies on children are not conducted. In addition, no such studies are conducted for biosymilars in countries with a high level of regulation, such as the European Union and the USA. This is due to the fact that the same molecules demonstrate identical efficacy and safety in all patient groups, including children, the elderly, etc.

***

GEROPHARM is a Russian biotechnology company, a leader in insulin development and production. Since the end of 2016, the company has been ranked first among manufacturers of human genetically engineered insulin (HEI) by sales volume. Today the company meets about 30% of the Russian Federation's demand for GIICH.

All stages of insulin production, including biosynthesis of a molecule, are carried out on the company's own production facilities in the Russian Federation. In 2018, with the participation of the President of the Russian Federation, a new plant of the company was opened in Pushkin (St. Petersburg).

The production capacity of the line at the Pushkin site is more than 1000 kg of substance per year, which after reaching the design capacity will fully meet the demand of the Russian population for insulin (about 800 kg per year), as well as expand export opportunities of the company.

The project was implemented with the participation of state development institutions - RDIF, FRP.

The company's portfolio in the field of endocrinology includes two genetically engineered human insulin (GIH) - Rinsulin® R and Rinsulin® NPH, as well as analogues of ultra-short, medium and long duration insulin - RinLiz®, RinLiz® Mix 25 and RinGlar®, respectively. Another 7 products (analogues of insulin and GIH) are under development.

Statistical data on the number of people diagnosed with diabetes in Russia and morbidity:

According to official data, there are 4.6 million people with diabetes in the Russian Federation, and the morbidity has increased by more than 20% in the last 5 years.

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