Russian insulin name of the year. How and where is insulin produced in Russia? Recent changes and progress

On May 20, 2016, at the Sanofi-Aventis Vostok plant (Orel), in the presence of the Governor of the Orel Region, V. Potomsky, the production of validation series of the latest generation of insulin was launched.

A new life-saving drug for the treatment of diabetes mellitus (DM), the latest generation basal insulin developed by Sanofi, was registered in the US and EU in 2015. Approved in more than 30 countries around the world. It has a smoother and more stable profile of action and therefore fewer side effects, as well as flexibility in use, which can help patients achieve better disease control.

latest generation insulin

The effectiveness and safety of the drug has been proven in clinical studies involving more than 3500 patients:

Triple units of insulin glargine per ml
More flexible injection schedule (within 3 hours before or 3 hours after the usual injection)
Stable and long-term control of blood glucose levels over 24 hours allows you to use the drug once a day
Cardiovascular and general security proven on insulin glargine in long-term studies.

Strategic production site

Sanofi-Aventis Vostok is the first and currently the only full-cycle pharmaceutical plant in Russia* for the production of modern insulins, Sanofi's contribution to the modernization program pharmaceutical industry RF "Pharma-2020" and increasing the availability of innovative drugs for Russian citizens.

* Except for the production of the pharmaceutical substance.

In 2015, the Sanofi-Aventis Vostok plant successfully passed the European inspection and received the GMP certificate of the European Medicines Agency. This will allow the export of insulins to the EU countries to begin in the second half of 2016. All drugs manufactured at the Sanofi-Aventis Vostok plant are identical in terms of quality, efficacy and safety to those manufactured at the Frankfurt plant.

High-tech production

The Sanofi-Aventis Vostok plant was built in full compliance with international standards GMP:

The total area of ​​the territory is 5.8 hectares
The total area of ​​the building is 12700 m2
Warehouse area - 5224 m²
Quality management systems - more than 20 physical, chemical and microbiological tests
Staff - 197 highly qualified employees, certified in the Sanofi insulin production center in Frankfurt.

Investment in production

Growth in production volume in 2014-2015 - 24%
The production capacity of the Sanofi-Aventis Vostok plant is 7.5 billion units of insulin per year
Market share of insulin - 30%

Diabetes is a socially significant disease

In 2013–2014 the largest epidemiological study of the prevalence of diabetes mellitus in Russia has been conducted to date:

26,000 people aged 20-79 from 63 regions of Russia
20% of the population are at risk
5.44% of the population have DM
54% of subjects diagnosed with type 2 diabetes were unaware of their disease
20% of people with newly diagnosed type 2 diabetes need immediate treatment

With anofi in Russia

The largest pharmaceutical company in Russia
Presence - over 45 years (since 1970)
Staff - more than 2000 employees
More than 10 large social programs
Clinical studies - 128 clinical centers, 2215 patients.

Social projects in the Oryol region

2011 - stage of the international bike ride for people with diabetes
2012–2014 – charitable program "Chance for Life" in support of women with breast cancer
Since 2015 - personal support program for patients with diabetes

17:30 — REGNUM In the industrial park Grabtsevo in Kaluga on September 19, a full-cycle plant for the production of insulin was solemnly opened. The ceremony was attended by the Governor of the Kaluga Region Anatoly Artamonov, Ambassador of the Kingdom of Denmark to Russian Federation Karsten Sendergaard, Executive Vice President of Novo Nordisk Mike Dustdar, representatives of federal and regional departments, public organizations, reports the correspondent IA REGNUM.

An insulin production plant has existed in Kaluga since 2015. At the first stage, the production carried out only secondary packaging of modern insulins in cartridges and syringe pens. Then work began on deepening the localization. In 2017, the plant received a license from the Ministry of Industry and Trade of the Russian Federation for the production of finished dosage forms of insulin. A workshop for the assembly of syringe pens was built and a workshop for the production of finished aseptic dosage forms and filling insulin cartridges was equipped.

One of the key events of the enterprise in 2018 is the launch of a full cycle of production of modern insulins, as well as the opening of a new workshop for the assembly of injection pens. The Kaluga plant uses the original substance produced in Denmark. The volume of output is planned at the level of 9 billion units of products per year, which is intended for Russian consumers.

In general, more than 8 billion rubles have been invested in the project, about 300 jobs have been created. The plant has modern equipment, advanced solutions in the field of energy efficiency and environmental protection. The total production area covers 13,000 m2.

Welcoming the participants of the ceremony, Anatoly Artamonov, Governor of the Kaluga Region, emphasized that Novo Nordisk, among other large companies, forms the basis of the Kaluga pharmaceutical cluster, helping to provide Russian residents with high-quality and affordable medicines, and to increase the effectiveness of diabetes treatment.

According to the Governor of Kaluga, in 2017, the growth in production of the pharmaceutical industry in the region amounted to 67%. Cluster enterprises produce 154 types of medicines, mostly innovative. Forty are in the registration stage, more than 20 are undergoing preclinical trials.

“In the next year or two, the number of drugs will increase to 215 - said Anatoly Artamonov. — By 2020, we plan that the volume of pharmaceutical products manufactured in the Kaluga region will be at least 10% of the total Russian production.”

Mike Dustdar, in turn, recalled that in 2018, Novo Nordisk celebrates the 95th anniversary of its founding, which took place shortly after the revolutionary discovery of insulin by Canadian scientists in 1921.

“For almost a century, the company's scientists and researchers have been creating innovative biopharmaceuticals to treat such a serious chronic disease as diabetes mellitus, which affects more than 600 million people today. Equally important, we consider our contribution to increasing the availability of treatment for patients around the world. The consistent investment policy of the company in the localization of high-tech production in Russia is fully consistent with the state policy of the Russian leadership in the development of the pharmaceutical industry. Today, by launching a full cycle of insulin production at a plant in the Kaluga region, we are taking another important step towards ensuring that almost 5 million Russian patients have the opportunity to be treated with modern, effective and affordable drugs that improve the quality and life expectancy,” he said.

The Ambassador of the Kingdom of Denmark to Russia Carsten Sendergard also highly appreciated the support of the Novo Nordisk project in the Russian Federation.

“The Kaluga region is one of the most favorable regions for business. Particular attention is paid to high technologies and innovations. I am sure that our joint efforts will lead to an improvement in the level of cooperation between Russia and Denmark.” , he emphasized.

Recall that the plant of the Danish company Novo Nordisk in Kaluga is the only enterprise in Russia that produces a complete portfolio of modern insulins. By launching a new workshop for the assembly of syringe pens in Russia, the company is moving to the production of modern insulins in pre-filled disposable FlexPen syringe pens. Pre-filled pens, which account for more than 89% of insulin analogues in Russia, are the most common type of insulin delivery device in the world.

The Russian company Pharmeco has signed an agreement with the Indian company Wockhardt on the creation of a project for the joint production of insulin in Russia, the government of India said.

For Wockhardt, the production of insulin biosimilars at the Pharmeco site will be the first production in Russia, says Pravin Sambrei, head of Wockhardt's representative office in Russia. “Now the question is being decided which drugs will be produced at our plant in Moscow, which ones - at a plant in the Moscow region,” explained Vitaly Smerdov, Chairman of the Board of Pharmeco. “Production volumes have not yet been determined.” We are talking about the production of genetically engineered insulins, said Sambrei.

Investments in the project will amount to at least $10 million, Smerdov said. According to him, at first, insulin biosimilars will only be packaged at factories, and at the end of 2017 - beginning of 2018, it is planned to start the actual production of drugs. Substances for them will be imported from India, he explained.

According to REM Analytics, in 2015 Wockhardt ranked eighth in the ranking largest manufacturers insulins on the Russian public procurement market with a sales volume of 17.4 million rubles and a market share of 0.11%.

In October 2015, Russian President Vladimir Putin instructed the government and Rostec to work out the issue of including measures to transfer the necessary technological solutions for the implementation of a project to create a full-cycle complex for the production of insulin and its analogues in Pushchino in state program"Development of the pharmaceutical and medical industry" for 2013-2025.

The production was planned to be implemented on the basis of OAO NPK Bioran, but the project stalled, and in April 2016, the head of the board of directors of Rostec's subsidiary Nacimbio, Vitaly Maschitsky, said that Rostec had abandoned plans to implement an insulin project based on Bioran". Perhaps it was precisely because of the failure of the insulin project that the former general director of Nacimbio, Nikolai Semenov, resigned, in August 2016 his Maryam Khubieva.

On the this moment in Russia there are several projects for the production of insulin. At the Sanofi-Aventis Vostok plant in the Oryol region, French Sanofi produces insulin. In 2013, a full-cycle plant for the production of insulin by the domestic company Geropharm. The Ural company Medsintez is also developing its own insulin project. In 2014, the American pharmaceutical company Eli Lilly announced plans for the production of insulin at the R-Pharm plant in the Kostroma Region. In 2015, R-Pharma's Ortat plant in the Kostroma Region began packaging medicines, and in the summer of 2016, the companies signed an agreement on full-cycle production.

Wockhardt was founded in 1965 in India. It is engaged in the production of medicines, pharmaceutical substances and biotechnological preparations. It supplies medicines to more than 90 countries of the world. Wockhardt has own production in India, UK Ireland, France and USA. The company's annual revenue for the fiscal year ended March 31, 2016 was $688 million.

The plant in the Oryol Region launched Russia's first full cycle of insulin production in the form of syringe pens, the most convenient for diabetic patients. Such devices appeared on the world market about 20 years ago and attracted patients with their ease of use, and the Oryol pen assembly line has been operating since 2011. The pen syringe is a drug bottle, a metered delivery mechanism and a replaceable needle, it makes it easier to inject and dose insulin, it creates a minimum of pain, and such a device is much easier to carry than a real syringe with ampoules.

The project was launched in pursuance of instructions from the Prime Minister at the time, and the governor of the Oryol region tirelessly emphasized the role of politicians and partners in making the project happen at all (it was implemented by the international company Sanofi, the third largest supplier of insulin to the Russian market, according to CMI Pharmexpert, while other Western companies that came to the Russian market with similar proposals have not yet been able to realize their plans). During the opening ceremony, it was emphasized that the plant solves two problems at once - providing Russians with high-quality drugs and reducing dependence on the supply of foreign drugs.

But the second goal will obviously not be achieved by this plant, at least in the near future: the substances themselves in dry form come to the Oryol plant from Germany.

Then this active pharmaceutical substance (crystalline human insulin or human insulin analogues) and auxiliary components for the preparation of solutions/suspensions are transferred to production from the raw material warehouse, weighed at a weighing station with laminar flow and loaded with a working stirrer into mixers pre-filled with water for injection.

The products of the plant in Orel are well-known both human and analog insulins - long and short acting. The quality is identical to that of the parent plant in Frankfurt.

The plant's technologists admit that not all Russian drugs are bad, but most of the production is not certified according to GMP standards ("Proper Internship”, Good Manufacturing Practice), so it is not clear how to distinguish a quality drug from a mediocre one. One way or another, insulin-dependent patients will still have to wait from abroad to receive a guaranteed high-quality drug.

Human insulins and their analogues are produced by genetically modified bacteria, that is, they are real GMO products. However, diabetic patients are not afraid of GMOs: substances synthesized by bacteria are of much higher quality and less allergenic for humans. The full cycle of insulin production in Russia has been implemented only at the level of low-capacity production on the basis of the Institute of Bioorganic Chemistry of the Russian Academy of Sciences in Moscow and at the National Biotechnologies enterprise in Obolensk (at site the latter company is reported to be GMP certified), but they pack insulin in awkward containers, mostly suitable only for hospital use. Also, they do not offer long-acting insulins.

Installation of own equipment for the production of syringe pens is very expensive and is not yet within the power of manufacturers. The state supports foreign companies.

Medsintez in Novouralsk and Ufa pack imported insulin, but due to small production volumes, its prices differ little from completely imported insulin. Foreign Novo Nordisk, Sanofi-Aventis and Eli Lilly remain the largest players in the Russian and global markets. According to 2011 data, Novo Nordisk accounts for 43.4% of the market, Eli Lilly - 27.6%, Sanofi-Aventis - 17.8%. Only in fourth place is Pharmstandard with 6%. Other manufacturers do not cover even 3% of the market. and "National Biotechnologies", offering a full cycle of production, had a modest 1.3 and 0.6% of the market, respectively.

Russian patients' needs for insulin are high and continue to grow.

According to official statistics (for 2011), more than 3.3 million people in Russia have diabetes, and about 285 million people in the world. However, experts from the Endocrinological Research Center believe that the real number of diabetics in Russia is three times higher - more than 10 million people. However, not all patients require insulin: both in our country and in the world, 90% of patients are patients with type 2 diabetes, non-insulin dependent on initial stage. Type 1 diabetes is most often hereditary. As a "trigger" are various infections, such as enteroviruses, susceptibility to which, in turn, is determined by the work of leukocyte antigens.

Type 1 diabetes most often develops at a relatively early age and is unrelated to lifestyle. Type 2 diabetes, on the contrary, occurs during life under the influence of a number of external factors, the main of which is malnutrition.

Scientists agree that the incidence of diabetes in the next ten years will increase significantly. Although the incidence of type 1 diabetes among children increased markedly during the 20th century (scientists are still argue about the reasons for this phenomenon), the main increase still comes from type 2 diabetes. The main reason for this is malnutrition and stress. Biologically, in such a situation, any nutrients are deposited in adipose tissue, so stress is to blame not only for the increase in the incidence of diabetes, but also for cardiovascular and oncological diseases. Particularly strong growth will be observed in countries in Asia and Africa, which are moving towards a "Western diet" and lifestyle.

Since any disease is easier to prevent than to cure, people at risk of developing diabetes can be advised to avoid stress, exercise, not overeat, and not smoke.

In the village of Obolensk, Serpukhov District, Moscow Region, the first enterprise in Russia for the production of full-cycle insulin was opened - from the creation of the substance to the packaging of products. The opening of this innovative production is also unique in that officials at all levels - from ministries to the head of the region and district - did not interfere with the creation of the enterprise, but even helped it. “This is a rare case, but no one really interfered with us,” admitted CEO Pyotr Rodionov. However, it would be surprising to meet opposition from officials to the creation of the first domestic technology of genetically engineered insulin, since it corresponds to strategic objective states - to ensure independence from Western suppliers of insulin. Having invested more than 2 billion rubles in new production, Geropharm-bio OJSC (part of the Geropharm group of companies in St. Petersburg) plans to borrow up to 20% in three years Russian market insulin due to the relatively low price of the drug. But without new government support measures, it will be difficult for the company to survive in the face of fierce competition with the world's three largest insulin producers, which collectively occupy over 90% of the Russian market and are de facto monopolists. Representatives of the antimonopoly service say that it will not be easy for the new enterprise to compete, since the largest market players have invested more than 10 billion rubles in “informing” (and in fact, in bribing) Russian doctors. And without separate educational work of the Ministry of Health, Russian diabetics will still be sure that one insulin cannot be replaced by another.

Factory facade

Press office photo

In the USSR, insulin was produced on the basis of animal pancreas. But almost all over the world, this insulin was abandoned in favor of genetically engineered (based on modified bacteria) due to many side effects, so its production had to be curtailed in the Union. For a long time, Russian diabetics have mostly been “on the needle” of Western manufacturers - these are Eli-Lilly, Novo Nordisk and Sanofi, which are world leaders and occupy about 93% of the Russian insulin market with a capacity of 350 million dollars a year. The last two companies, by the way, have their own factories in Russia.

Currently, only three produce insulin. Russian companies– Pharmstandard, Medsintez. But they make it on the basis of a substance purchased abroad, dealing, in fact, only with its mixing with solutions and product packaging. Until recently, Geropharm also produced insulin from a foreign substance. Therefore, the new high-tech complex "Geropharm-bio" is the first full-cycle production of genetically engineered insulin in Russia. The strain (bacterium) that is cultivated to produce the substance was developed and patented by the company about ten years ago, almost since its founding. Clinical trials of insulin, made on the basis of a unique strain, were carried out for six years. After receiving a positive opinion from the Ministry of Health, Geropharm began construction of a new plant in the village of Obolensk, Serpukhov District, Moscow Region, and completed it in less than two years.

Reference

OJSC Geropharm (formerly OJSC National Biotechnologies) is part of Geropharm Group of Companies, St. Petersburg. Initially, the enterprise was organized in 1998 specifically for the implementation state task– creation of the Russian technology of genetically engineered insulin. Work on the creation of a new domestic technology was carried out within the framework of the Diabetes Mellitus program, the key aspect of which is the strategic independence of the state from Western suppliers of insulin. The volume of investments in the construction of the plant amounted to 1.5 billion rubles. Previously, about a billion rubles were invested in the creation of the strain. The area of ​​the enterprise is 2.5 hectares, the area of ​​​​the premises is 10,000 square meters. m. The planned production volume is 25 million bottles and 5 million cartridges per year. It is planned to reach the design capacity in the summer of 2014.

Space sterility

Compact, as if hidden away from the eyes in the dense forests near Moscow, the enterprise survived the invasion of several thousand people. Representatives of ministries and departments, entrepreneurs, doctors and many others had the opportunity to observe the launch of high-tech production. However, no one was allowed into the holy of holies of the enterprise - a building where a valuable bacterium is grown for the production of a substance. Its formula and cultivation technology are strictly classified.

The guests were introduced to the main production in small groups of 10-12 people. While we change into disposable sterile gowns, the head of the quality control department instructs us:

- You have no right to touch anything with your hands, you also have no right to lean on devices. It is forbidden to touch the face, - says a strict woman.

- What's with the face?

“The skin peels off, it pollutes the atmosphere of the workshops.

After that, I even wanted to put on a gauze mask - I wouldn’t breathe anything extra for super-sterile strategic production.

The tour was conducted by a girl of pleasant appearance and exceptional delicacy, more precisely, a process engineer, Elizaveta Kantsevaya. She also conducted her briefing, teaching how to properly handle her hands with a special solution. Kind of science.

The first thing that is shown to the guests is the water purification shop. People do not work here - only units that are controlled by an invisible engineer behind a computer. The outlet water is sterile - just H 2 O and that's it. It is used both for washing equipment, vials and cartridges, and for preparing an insulin solution. In the second workshop, insulin itself is actually made - they mix the substance delivered from the neighboring building with water. This is done by only two people, packed in protective suits. More precisely, they monitor the readings of instruments that perform all procedures.

From here, the solution enters the next room - a small laboratory, where one technologist checks the concentration of the solution using instruments. If there are the slightest deviations from the norm, technologists from the first workshop adjust their devices in order to bring the solution up to standard. Of course, we could watch their work only through the window. It's amazing, but, in fact, only three of these people (not counting the army of microbiologists) make the main product - the first domestic genetically engineered insulin.

At the insulin bottling area, there is the most sophisticated apparatus that washes the cartridges and vials, which are then delivered to the neighboring, tightly closed workshop, where the containers are filled with a solution and sealed with a lid. Here, too, only three people in protective suits are controlled.

The last step is packaging. Here is a long conveyor where cartridges and vials are labeled, packaged and stacked in packages and boxes.

- And why does the conveyor consist of devices manufactured by different companies? I ask Elizabeth. - Labels are applied by one, packed by another, packed by a third?

– Because we chose devices only from the world's leading manufacturers, exceptional leaders in their field. There are no analogues to these devices in Russia. When designing a production line, they had to interconnect their devices.

So things will soon come to the point that the apparatus of one company will apply glue to the label, and the other will slap it on the bottle. Simply because this particular company knows how to apply glue better than another.

At the exit, we were rushed to change clothes: a landing of officials, led by the Governor of the Moscow Region, Andrey Vorobyov, who had just arrived by helicopter, was advancing on our heels. They say he deliberately interrupted his vacation to participate in the opening of the plant. He was accompanied by State Duma deputy and public figure Iosif Kobzon, who, as it turned out, lobbied in various departments to open production.

“It is dangerous to open production outside the mainstream of state policy”

“I am glad that once upon a time I invited the director of Geropharm, Pyotr Rodionov, to be an assistant to the State Duma,” Iosif Kobzon went deep into his memories at the opening ceremony of the plant, which took place in an impromptu conference room. – This is an energetic young man who is focused on creation. I often bothered both Deputy Prime Minister Olga Golodets and Governor Andrey Vorobyov so that this day would come as soon as possible.

Deputy Director of the Endocrinology Center for scientific work, Director of the Research Institute of Diabetes, Corresponding Member of the Russian Academy of Medical Sciences Marina Shestakova did not restrain her delight.

“We have been waiting for the opening of this plant for a long time,” she said with warmth in her voice. “This is the first step towards ensuring the country's independence from Western insulin producers. This is very important, because only according to official statistics we have 3.7 million people with diabetes. In fact, there are about 12 million of them, which is almost 10% of Russians. Our task is to eventually provide them with high-quality domestic insulin. We are happy for you and for Russia, we hope that you will not stand still and start creating insulin analogs soon.”

(By the way, the reason for the discrepancy between the real number of diabetics and official statistics is that not all people know about their diabetes, which does not always make itself felt.)

More than ten people spoke at the ceremony - representatives of ministries, departments, even cultural figures. The launch of the enterprise itself was symbolic: Pyotr Rodionov and several officials put their hands on interactive screens - and the devices stopped after the tour started working again. Now seriously and for a long time.

To be honest, I was embarrassed that many speakers at the opening ceremony thanked representatives of ministries, the governor of the Moscow region and even the head of the district for the opening of the plant.

“What did they actually do for you? - I ask the hero of the occasion, the general director of Geropharm, Petr Rodionov. – Did they not interfere or did they do what they were supposed to? What is the merit?"

“Firstly, no one really interfered with us at all,” Peter Rodionov answered frankly. - This is an extremely rare case when no one interfered all the time while we were dealing with this topic. We were even inspired, in the end we decided to challenge the monopolists. We did not face bureaucracy, we were helped with the provision of infrastructure. We bought the land at the cadastral value. We were helped by the fact that there is a government policy to develop our own pharmaceutical production, the modern pharmaceutical industry. The goal was to have 80% local production of insulin, which is why everyone was so interested in creating our plant.”

Move the giants

Although Timofey Nizhegorodtsev, Head of the Social Sphere and Trade Control Department of the Federal Antimonopoly Service of Russia, shared the general joy of opening the enterprise, he pointed out the problems that it would face:

“This plant is a dream for us antimonopolists. Because the market has a monopoly of three major global manufacturers, and they dictate prices. This plant will break the situation from the inside, real competition will appear, and prices will become lower, we are already seeing this. But there's a problem. Many tried to produce their own insulin, but they failed for one simple reason. We do not consume what we choose, but what the doctor chooses. And monopolists are working with them, who have invested billions of rubles in this. For 20 years they have been systematically holding press conferences, round tables, where they treat our doctors. As a result, they formed an opinion among patients that Russian insulin is of terrible quality, that one must trust those who have been producing it for a long time. This, to put it mildly, is not true - after all, our insulin passes all quality tests. ”

According to Timofey Nizhegorodtsev, monopoly companies “motivate” doctors by paying them remuneration for supposedly giving lectures:

“For over 20 years, companies have formed an opinion that is 90% unfair. In every way they prevent the emergence of such industries, which Peter opened today. We did an investigation and found an interesting thing: lecture agreements are made with doctors. What this is is clearly demonstrated by the following fact: according to one of these agreements, it turned out that the doctor lectured almost around the clock, and in different parts of the world.

This was a reproach to the Ministry of Health, which, according to Nizhegorodtsev, can change the situation by organizing schools for diabetics, where they will be educated about the proper quality of domestic insulin.

“Pyotr, you still have a long and hard fight ahead of you, if the Ministry of Health does not help you, you will lose it,” the FAS representative summed up.

We are talking about the fact that unscrupulous doctors have formed an opinion among patients that switching from one insulin to another, even if it is more effective, is harmful and even dangerous. It is the Ministry of Health that, through separate educational work with patients, can convince them of the opposite. And then the domestic manufacturer will have a chance to press the monopolists.

“I would not want statements to appear in the press that all the doctors have been bought from us,” Elena Maksimenko, assistant to the Minister of Health, repelled the blow. – Look at the conditions in which they live and work, and everything will become clear. In particular, thanks to the efforts of doctors, the opinion in society has changed: according to VTsIOM, for the first time in many years, Russians equally evaluate the quality of domestic and foreign drugs. As for supporting domestic producers, yes, we are glad that the monopoly position on the insulin market may change. We confirm that prices can be reduced as a result of competition and up to 80% of the current price. But we have an obligation to provide equal measures of support to everyone. What, in fact, is the merit of the ministry in opening this production? That we are open to dialogue. We discuss any innovations and changes in laws with our pharmaceutical manufacturers.”

General Director of the analytical agency "DSM Group" Sergey Shulyak confirmed that both doctors and patients have stereotypes about the impossibility of changing insulin and the low quality of the domestic drug for diabetics. But he suggested paying attention to the quality of public procurement.

“The inventiveness of the people who are involved in procurement is very large. They know where to put a dot or a comma so that a specific company wins the tender,” says Sergey Shulyak. – Of course, the market is monopolized by three companies, and not only in Russia, but all over the world. With varying degrees of success, it is possible to move this trio. Yes, this trio uses different technology of competition. Russia consumes 10 billion packs of insulin per year. State allocations are 10 billion rubles, which is 1% of the entire pharmaceutical industry. Why shouldn't the state provide support to local producers? And at tenders, take into account the locality of production as a significant advantage. This would allow the funds saved on insulin to be spent on the development of domestic medical science, on the creation of new industries within the framework of PPP, and much more.”

In a word, the state, which has so far simply not interfered with the creation of the first full-cycle insulin production, can also help. Moreover, it is already taking the first steps towards this.

“We, in turn, were greatly helped by the fact that the public procurement system became transparent, we began to see who sells and how much. As a result, we actively participate in tenders in the regions, in some we occupy up to 50% of the market for insulin, and with a new product, including through the public procurement system, we hope to take up to 20-30% of the Russian market,” Petr Rodionov does not lose optimism .

The Russian insulin market, however, is not developing so slowly: from 0.7% of the total volume in 2005 to 7% in the past. It is indicative that during the same period the price of imported insulin was constantly decreasing. So the point of supporting the production of domestic full-cycle insulin is obvious (for those who make insulin from Western substances, it is more difficult to compete, since the local market situation does not affect the cost of the substance).

Sergey Tsyb, director of the department of chemical-technological complex and bioengineering technologies of the Ministry of Industry and Trade, noted that the opening of the Geropharm-bio plant is a vivid example of the successful implementation of public-private partnership.

“Since 2008, the Ministry of Industry and Trade has been systematically trying to improve the state policy for the development of the pharmaceutical industry. And it is very gratifying that over the past two years of implementing this policy, we have monthly or quarterly new pharmaceutical organizations, laboratories, research centers that are being implemented as part of PPP. Today's event is another such joint success of ours in the development of the industry. In this regard, we will increase our participation in terms of new expert support measures that will stimulate the development of pharmaceutical production.”

Petr Rodionov has no doubt that cooperation with the Ministry of Industry and Trade and the Ministry of Health will help Geopharm-bio to occupy a solid niche in the market and develop further towards the creation of insulin analogues:

“We understand that we are following the state policy, without such a policy it would be simply dangerous to open production. We are counting on great support - giving preferences to those who make insulin from their substance, and not just pack it. There is such a decision, but it has not yet been approved.”

If the state decides to give preferences to full-cycle insulin producers, then it is quite possible that other Russian companies will start opening similar enterprises. Only with state guarantees can one take the risk of long-term investments in the creation of one's own strain. And then, by increasing competition and lowering the price of insulin, the state will be able to save significant funds.