According to statistics, approximately 10 million Russian residents have been diagnosed with diabetes. It has been established that such a disease is primarily associated with a disruption in the process of production of its own insulin by pancreatic cells. In this case, the patient’s normal metabolism is completely disrupted. The solution is to manually inject insulin into the body every day. Current rate state program aims to ensure that all vital drugs are created at domestic enterprises. Insulin production also develops in this vector.
Current situation in Russia
At one time, the World Health Organization issued a recommendation that literally said that every country with a population of more than 50 million people should open its own factories for the production of this drug. Otherwise, diabetics may experience periodic difficulties in acquiring the medicine they need, which is not acceptable. In Russia, only one pharmaceutical company has managed to fully establish its own insulin production capacity - Geropharm.
Today, two types of domestically produced products are sold on the market. Insulins are supplied either as substances or as medicines. Recent policy changes and the imposition of sanctions on the import of foreign products have obligated the government to direct that higher production capacity be deployed as soon as possible. In addition, in the city of Pushchina it is planned to create an entire complex that will produce all types of hormones.
Import substitution opportunities
On at the moment It’s definitely too early to talk about the full-fledged withdrawal of the domestic product and its competition with large Western companies. However, within 15 years insulin Russian production is quite capable of capturing a share of 30 to 40 percent of all hormones sold in the country. The first attempts at such reformations began back in the days of the USSR, but the drug produced in those years was of animal origin, and the degree of its purification left much to be desired.
The reorganization failed in part in 1990 for the simple reason that the country faced serious financial problems. Today small production are gradually starting to gain momentum. Many companies in Russia have attempted to provide a stable supply of the product to pharmacies, but at the same time used a foreign substance. In the current realities, it is too early to hope for a full replacement of imported insulin.
Latest changes and progress
One of the new production facilities was planned to open in 2017. The cost of the final product had to be lower than that foreign analogues. By doing so, the company planned to achieve healthy competition. The program was designed to solve many problems associated with diabetes in the country, as well as improve the financial situation.
In addition, in the Moscow region they are going to build their own insulin production plant, where the product will not be inferior to imported samples in terms of quality. Currently, this factory successfully produces about 650 kg of the substance every year.
The state plans to fine-tune the production of both ultra-short and long-acting hormones. There are four positions in total that will soon fill pharmacy counters. The end consumer will be offered various forms of the product, including vials, syringes, disposable and reusable pens, as well as special cartridges.
Checking the quality of products
Scientists have found that the most optimal hormone that does not cause side effects is genetically engineered insulin. Its physiological properties and qualities almost completely replicate those of the natural version. Of course, first of all, tests and tests were carried out, because when producing insulin, quality control is placed above all else. Research has proven a good positive effect from the use of the drug, a sufficient level of reduction in blood glucose and the complete absence of any allergic manifestations with prolonged exposure.
Experts concluded that the transition of patients to new domestically produced drugs should not cause any discomfort or ailments. Also, before the production of insulin, additional tests were carried out on the drugs Rinsulin R and Rinsulin NPH. In this case, the researchers did not note any significant differences from foreign analogues. For end consumers, the most convenient thing was that they would not have to, be that as it may, change their usual routine for taking and dosing the hormone, as well as the method of carrying out the procedure itself.
Description of production technology
The process includes all the main stages of manufacturing any biotechnological product. The final insulin is crystalline. It is then used to develop injection solutions that are intended for type 1 and type 2 diabetics. In total, there are seven main stages in insulin production technology, listed below.
- Preliminary. Preparation and purification of water, air and production premises, equipment is sterilized. The primary chain of molecules is then created through chemical synthesis.
- Preparation of nutrient solutions and cell culture. The necessary genes are introduced into living matter to produce the required compound.
- Suspension cultivation process. Cells are grown in special bioreactors.
- Isolation of culture. The water is separated and the cells are sedimented and filtered to maintain maximum integrity.
- Chromatographic purification of a substance. A variety of methods are used, including frontal, gel permeation and anion exchange.
- Obtaining a protein culture. An unfinished insulin molecule is synthesized.
- Freeze drying from oven. Also on at this stage The product's compliance with the standard, packaging, labeling and shipment are checked.
Advantages of domestic insulin
Scientists plan to use a special technique in the manufacture of the drug. While the technology for large-scale production of a genetically engineered product is being prepared, at the same time, new factories for the production of insulin are being built in Russia. Thus, the infrastructure is currently experiencing a stage of active growth and development.
Domestic insulin will be produced according to a full cycle scheme, which is an innovation in world practice. The substances will either have to be imported from foreign partners or produced in-house. Most likely, both options will be combined as necessary. Current research is carried out at the Moscow Institute of Bioorganic Chemistry of the Russian Academy of Sciences in Obolensk. It is worth noting that this organization is not establishing mass production, but is only studying the issue for the subsequent increase in capacity in the industry.
Features of manufacturing in Russia
It is also planned to introduce some advanced technologies. For example, for the production of insulin in Russia, methods of separation, gel filtration, enzymatic treatment, renaturation and chromatographic purification are being tested. Modern equipment at the already operating Biotekhnologii plant allows packaging finished products in special multi-dose disposable containers, which are commonly called cartridges.
Experts assure that they follow all international standards in the production of medicines. All personnel are carefully selected and undergo appropriate testing of practical skills and theoretical knowledge of the subject.
Classification of the Russian drug
Despite the special emphasis on the genetic engineering option in manufacturing, domestic techniques allow us to move in other directions. For example, it is allowed to use human or biosynthetic genesis in the production of insulin. Scientists are also exploring the prospects of extracting the necessary substances from pigs, whales and large cattle.
The resulting insulin will differ, for example, in the duration of action, which can be directly related to the required frequency of administration by the patient. The frequency of daily use will vary from two to six times. Thanks to such insulin therapy, a complete imitation of the physiological process of secretion of this hormone in the human body will occur.
The future of domestic production
Industry experts said there are immediate plans to change the way diabetics use the drug. If today almost always the administration of a substance occurs through an injection, then in the future this option will be changed to special patches or an artificial pancreas. The developments, of course, are still only on paper, but insulin production is already actively developing.
On May 20, 2016, at the Sanofi-Aventis Vostok plant (Orel), in the presence of the Governor of the Oryol region V. Potomsky, the production of validation batches of the latest generation insulin took place.
A new vital drug for the treatment of diabetes mellitus (DM), the latest generation basal insulin, developed by Sanofi, was registered in the USA and EU in 2015. Approved in more than 30 countries around the world. It has a smoother and more stable action profile and, accordingly, 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 3,500 patients:
Triple units of insulin glargine per ml
More flexible administration schedule (within 3 hours before or 3 hours after regular administration)
Stable and long-term control of blood glucose levels over 24 hours allows the drug to be used 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 one in Russia pharmaceutical plant full cycle* by production modern insulins, Sanofi's contribution to the modernization program pharmaceutical industry RF "Pharma-2020" and increasing the availability of innovative drugs for Russian citizens.
*Excluding the production of pharmaceutical substances.
In 2015, the Sanofi-Aventis Vostok plant successfully passed the European inspection and received a GMP certificate from the European Medicines Agency. This will allow the export of insulin to EU countries to begin in the second half of 2016. All drugs produced at the Sanofi-Aventis Vostok plant are identical in terms of quality, effectiveness and safety to those produced 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
Total building area – 12700 m2
Warehouse area – 5224 m²
Quality management systems - more than 20 physical, chemical and microbiological tests
The staff consists of 197 highly qualified employees certified at the Sanofi insulin production center in Frankfurt.
Investments in production
Production growth in 2014–2015 – 24%
Production capacity Sanofi-Aventis Vostok plant – 7.5 billion units of insulin per year
Insulin market share – 30%
Diabetes mellitus 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 years from 63 regions of Russia
20% of the population are at risk
5.44% of the population have diabetes
54% of subjects who were diagnosed with type 2 diabetes did not know about their disease
20% of people newly diagnosed with type 2 diabetes require immediate treatment
WITH anofi in Russia
The largest pharmaceutical company in Russia
Presence – more than 45 years (since 1970)
Staff – more than 2000 employees
More than 10 scale 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 – charity program “Chance for Life” in support of women with breast cancer
Since 2015 – personal support program for patients with diabetes mellitus
Production of insulin in Russia.
Russian scientists have developed a technology for the production of genetically engineered insulin and organized its pilot industrial production. But for now, the state continues to purchase the drug abroad - last year alone, $160 million was spent on this.
Whole market medicines in Russia was estimated in 2007 at 280-300 billion rubles, of which domestic drugs amounted to 50-60 billion. And if we take drugs covered under the Additional Drug Supply Program (DLO), then the share of Russian Chinese drugs in it amounted to only 10%. With a drug like insulin, the situation is even worse.
The following types of insulin exist in the world: animal origin(pork, cattle), biosynthetic(modified pork), genetic engineering, modi- modified genetically engineered, synthetic. Until the 1980s insulin was produced exclusively from animal raw materials, namely from the pancreas of pigs and cattle. Only in 1982 was the technology for the production of genetically engineered human insulin developed by the method of genetic modification of microorganisms. Currently, the share of genetically engineered insulin throughout the world is steadily increasing and in 2006 amounted to more than 90%.
In our country, as well as throughout the world, the number of people with diabetes is constantly growing; currently there are 2 million people, and more than 750 thousand need daily insulin. This shows how profitable and promising the market for this drug is. However, now the share of Russian-made insulins, according to Pharmexpert, is in monetary terms is about 2%, and in natural terms - 3.5%. The insulin market in our country is estimated at 450-500 million dollars. Of this, insulin itself costs 200 million dollars, sugar-lowering drugs cost 130 million, and more than 100 million dollars are spent on diagnostics. We already have enterprises that produce insulin based on domestic developments. This is Obolensk, near Moscow, where they produce 30 kg of insulin per year, and another 5 kg are produced directly in Moscow.
Pilot production in Obolensk produces a product using European equipment, which does not differ in characteristics from imported analogues. The line complies with GMP (Good manufacturing practice) requirements. The capabilities of the line make it possible to provide insulin to Moscow, the Moscow region and Saint Petersburg. The automation system for insulin production on the new line of JSC National Biotechnologies was developed using the integrated SCADA / HMI and Softlogic TRACE MODE system. National Biotechnologies declare that they are ready to meet 50% of Russia's insulin needs. A business plan has already been developed for the construction of a plant with a capacity of 200 kg of substance - 13 million bottles per year. The cost of the plant is estimated at $80 million. According to the domestic manufacturer, insulin from Obolensk is 20-30% cheaper than foreign analogues, and this applies to all insulin produced in Russia.
At the end of last year, the first workshop in Russia for the mass production of genetically human insulin was launched in Novouralsk (Sverdlovsk region). Insulin in the Sverdlovsk region. will be prepared from French starting materials. The insulin production technology itself is still new for us and, moreover, so complex that the organizers did not dare to rely on domestic specialists and attracted technologists from the Czech Republic, Germany,
and at first, the process will be controlled by English colleagues. The plant management calculated that if 24-hour production was established, the new workshop would be able to produce up to 400 kg.
This year, 2008, it is planned to open factories for the production of insulin in Pushchino, near Moscow. Funds invested in investment project, amounted to 3 billion rubles. This will also be an enterprise for the production of genetically engineered human insulin with a capacity of 120 kg of the substance per year. The project involves the construction of a workshop for the production of finished dosage forms of insulin (up to 3 million bottles (5 and 10 ml) of drugs).
In the Oryol region. An insulin plant will also be opened together with the Polish company Bioton. The products of the Oryol plant will take up more than 30% of the insulin production Russian market. In addition, Oryol insulin is planned to be supplied to Western European countries.
All this will allow Russia to avoid purchasing this important drug abroad.
Until now, Russia is almost completely dependent onforeign-made insulinstva. Today the main import-insulin terers to Russia are -Xia DanishNovoNordisk(about 50%), SwissEliLilly(30%) and Franco-German Sanofi - Aventis (20%). It is worth noting thatEliLillySince 2005, it has been producing the drug in Ukraine according to the Ukrainian-American program from the company’s own materials.
How many bosses I have had, all of them unanimously do not like it when employees go on sick leave. And if someone finds out that there is a chronic disease, this will entail some sanctions. Moreover, diabetes is a disease that people know little about, because no one, as a rule, advertises it. Everyone thinks: it’s one thing if there is simply some problem and it can be corrected with diet or lifestyle. It's another matter if a person takes pills. Well, if there are injections, this is the end and the last stage. Although the only problem is that insulin is not absorbed in the stomach and injections are required. “It’s just a way of taking medicine,” says Elena [name changed]. The heroine of the material asked not to indicate her personal information due to possible problems at work.
Substitution
Elena's case is rather exceptional. She has been living with diabetes for 18 years, she is in the first stage (the one that requires injections). At first she was prescribed a Danish drug, but it was canceled due to a strong rejection of one of the components. Then they switched to American Humulin. Now it is produced jointly with Russia - raw materials are brought to us and packaged. The medicine suited Elena perfectly. So she gave birth to a healthy baby without an insulin pump [a special device that automatically delivers insulin to the body during childbirth].
In February 2017, Elena came to the clinic for another dose of the drug.
I came, as usual, to fill out a prescription. There were no changes in the recipe, it was still indicated: insulin, the active ingredient is isophane. In the book, in the “disabled person,” as I call it, the name of the drug is written: “Humulin.” I submit to the pharmacy window a prescription with all the stamps and this very book, in which they must make a record of what drug they gave me, and my signature must appear. The pharmacist sees that this is Humulin, and he must give it to me. But instead I receive a box with the inscription “Rinsulin,” says Elena.
Biological drugs cannot be shuffled around like headache medications or vitamins. Insulin needs to be changed in a hospital or at least under the supervision of a doctor - it is integrated into almost all processes of the body. And to transfer a patient from one biological product on the other, good reasons are needed: sugar is poorly reduced, an allergic reaction. Someone should be responsible for changing the patient's medication - Elena was simply given the drug at the window. She didn't want to take it.
I say: “What is this?” The pharmacist replies: “This is what you need.” I say, “No, it’s not Humulin.” She tells me: “This is now ‘Humulin’.” I say, “This is not Humulin.” “Humulin” says “Humulin.” I can show you the box. Here on the box it says: “Rinsulin.” Pharmacist: “Girl, don’t delay, if you don’t like it, I can give you “Insuman.” I say: “No, these are not the drugs that I need, I don’t want to risk it.”
Elena still took the medicine and put her signature on the disabled person’s card.
Other patients in similar cases, out of ignorance or frivolity, leave with the words: “Oh, is this insulin now? “Okay,” says Elena. She went to her endocrinologist. She listened, said: “Don’t worry,” and added that “Humulin” is no longer there, when it will be is unknown, because there is an order to transfer everyone to Russian-made drugs.
Children are not touched. The most disturbing part of the population is excluded from this process: these are mothers who will lift everyone up with pitchforks and destroy everything in their path. Those who are newly diagnosed do not care where to start. Why touch everyone else? If I live on this insulin, I live normally, and there is no reason to transfer me to another drug? I said that starting tomorrow I would go ask questions. In the evening she called me back and said that she had discussed the issue with the head of the clinic, with the clinical pharmacologist, that, indeed, I have the right to get what I need, and they are ready to give me the last pack of Humulin from the clinical pharmacologist’s stock. “I received it the next day,” says Elena.
According to doctors, she has the right to take the drug that suits her. And they can supposedly purchase Humulin especially for it - but in the conditions of import substitution, will anyone go to auction for the purchase of an American drug? The supply given at the clinic will last Elena for a month. For the first months, Elena’s family will be able to purchase medicine abroad or in pharmacies at their own expense, but what will happen then?
Order
Elena tried to find reviews about the drug "Rinsulin" on specialized forums. Diabetics willingly share information about medications, but there are few mentions of the Russian drug. Only official data: how many clinics took part in the trial, the results of using the drug, the obvious hypoglycemic effect, and the like.
On the largest forum I found only one review from 2015. The man agreed to switch from Humulin to Rinsulin, and it is not helping him. Sugars wander in all directions and if he gives a shot [an additional dose of insulin, which is given during stress or consumption of sugar-containing foods] with “Rinsulin”, the effect is practically zero, and if with the remains of “Humulin”, the effect is normal. Another review was neutral: “Well, I switched and switched, without any special consequences.” And one more (as a veteran of diabetes, I will say that a diabetic would not write such a thing): “I tried this, I tried that, Rinsulin is the same as everyone else.” How did you try this and that, if the endocrinologist selects the drug for you individually? It’s not like going to the pharmacy and buying some analogue instead of no-shpa,” says Elena.
“I was also transferred from Protafan and Actrapid to Rinsulin, the effect was the same as Wall described. The trend towards a decrease in the effectiveness of maintaining blood glucose levels was confirmed with lightning speed. Sugar with them began to go off scale to 25. It lasted me for three days. I returned to “Protafan” and “Aktrapid”. I will switch to another insulin, there is no way out. I want to try Lantus with Humalog,” writes volniy-s.
“I came to the endocrinologist for a prescription, she told me that there is no imported insulin, we need to switch to Russian bioinsulin! They say that you need to go to the hospital for adjustments! Honestly, I'm shocked. I have been using Humalog/Lantus for more than five years. Has anyone encountered this and what should I do?” - asks kif.
Most likely, this will not be the last entry. The experiment on introducing Russian drugs continues. And not always predictable.
Defying logic
Sergei Veselov from Murmansk talks with diabetics from other regions of Russia: medications, he says, are changed in different ways. He was suddenly replaced by the Russian Lantus with the German Tujeo. Both: insulin-glargine.
The Murmansk Ministry of Health, in response to a request from “”, explained that they also purchase insulin, relying on Resolution No. 1289, which has one more nuance: the ban on foreign drugs is valid if at least two suppliers enter the auction, one of whom offers foreign medicine manufacturer. In the case of Tujeo, only one application was submitted (here the resolution ceases to be in effect), and the foreign drug ended up in Murmansk clinics.
True, the Ministry of Health of the Murmansk region in its response to the request indicated an incorrect purchase number insulin glargine dated February 27, 2017 is an auction for the “Supply of reagents and consumables for the radiology department." Perhaps by mistake.
We found the necessary purchases ourselves. In February there were two: approximately 12 million rub. And 2 million rubles. respectively. In both cases, the auction for the supply of Tujeo was won by the only St. Petersburg supplier: Non-public joint stock company"Medical-Pharmaceutical Company North-West". It is noteworthy that the amounts procurement Russian "Lantus" by the Ministry of Health of the Murmansk region in the same month does not exceed 140 thousand rubles.
And yet, the Ministry of Health purchased Lantus. And not only in February - there was another purchase in March. But Sergei Veselov was given a prescription at the clinic and told: “Pay attention to the dosage.” The prescription included a generic name: insulin glargine. He called the point for issuing preferential prescriptions, where they confirmed that patients were now being given an analogue. Sergei went to the clinic again.
I say: “Analog is an elastic concept. As far as I know, this is a different drug, its effect may be different. How will my body react to it? To which they simply told me: “If you don’t like something, write a refusal to take insulin and leave the office.” I say: “Got it.” I turned to the deputy chief physician, he was shocked, he said that the nurse was simply not very motivated in terms of salary and she simply had no desire to tell the diabetic about what kind of drug it was. As a result, I heard from the deputy chief physician what kind of drug it was. But I was still surprised, how is it possible to introduce a new drug without consultation, without supervision? It’s simple: don’t worry, that’s all,” says Sergei.
The nurse was punished for inattention. Sergei still has a supply of the old drug left. He hasn't switched to a new one yet - he's afraid.
I'm afraid why? I communicate with diabetics from different cities, asking who has what. One's sugar levels are so low that he feels sick every day. They began to inject in the same way as the doctor told them, the same number of units. Others say that we cannot get rid of sugars: 20, 21, this is a very bad indicator. That is, everyone’s body reacts differently. This already suggests that everything is not so simple: take it, inject the same dose and rejoice. Moreover, the new drug has a longer action, in my opinion, by six hours. That’s why I don’t move on and worry. On social networks and forums, everyone asks each other: how are you, how are you feeling? Some say: I shouldn’t have switched at all, because now there is uncontrollable blood sugar, which means there are more expenses for controlling glucose levels,” said Sergei.
Elena is also afraid to switch to a new drug. But the supplies of pharmacists and doctors in clinics are not unlimited. She found a pharmacy in Moscow that works directly with the Humulin supplier. An annual supply of the drug will cost her 20 thousand rubles. The main thing is that the supplier now does not leave the country for good. And so, it seems, there is little choice: take what they give and go.
As the Murmansk example shows, there is an option: one supplier can enter the auction, and a contract will be concluded with him, even if he offers a foreign drug.
"analogue" analogue
Dear Natalya
In the case of hormones, they talk about replacements only with hormones of the same therapeutic effectiveness; there is a term for them - biosimilars.
Similar to NOVORAPID - in terms of action profile, maybe. HUMALOGIST.
Neither one nor the other is produced in Russia.
In addition, there are differences in the form of the substance, the form of the preservative.
If you were satisfied with NOVORAPID
don't agree to a replacement
they do not seek good from good.
And if this is not Humalog, strongly disagree
watch the interview with Suvorov A.V. on this site
Or read:
« AiF": - Alexander Yurievich, in 2013, patents for insulin analogues (the most modern and effective drugs used for diabetes) expire. It is expected that cheap Indian and Chinese drugs will flood the market. What will this lead to?
A.M.: - For pharmaceutical companies, the production of insulin and its analogs (they are paid for by insurance companies everywhere) is a tasty morsel. Therefore, companies often prefer to enter the market not in a civilized way, conducting independent studies proving the quality of the drug, but “ administrative", offering more low price. For our health officials, the deciding factor when choosing a drug is not quality of life, but price. As a result, patients may be switched to new, less effective drugs.
« AiF": - But perhaps the savings are justified?
A.M.: - People with diabetes take medications for life. Their condition directly depends on the quality of the drug, which is determined not only by compliance with the chemical formula, but even by the metal of the reservoir in which the bacteria that produce insulin are located. Throughout the world, to prove the effectiveness of a new drug, the manufacturer must re-run all stages of clinical trials. In Russia, three months of drug testing on diabetic patients is sufficient, after which registration occurs. If during this time the patient does not get worse, the drug is considered to be normal. Further quality is not monitored.
« AiF": - Will a doctor be able to prescribe to a patient not a cheap Indian drug, but an expensive European one?
A.M.: - Theoretically it can, but this will require serious justification. Who will collect this evidence?
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