1. Pharmaceutical Industry Development Trends

   Abstract \u003e\u003e Economics

   ... registration domestic medicines; 7.training specialists for development ... generic) and copied medicinal product (copy). 2.2.1 Drugs generics and copies The drug-generic called medicinal a drug ... the strongest states... IN...

2. Economic and legal aspects of the firm's functioning in the pharmaceutical market

   Abstract \u003e\u003e Economic theory

   In countries The European Union pharmaceutical market ... active role states... Ministry of Health ... at registration medicines ... elaboration regulatory and technical documentation and technology for the production of finished medicinal products, primarily drugs-generics ...

3. Research work in a pharmaceutical company

   Abstract \u003e\u003e State and law

   An important indicator of opportunity states counteract external and ... drugs-generics... Along with traditional chemical and pharmaceutical developments, ... it is known that the procedure registration takes several years ... health care and European Union stand for ...

4. Development trend of the global pharmaceutical market

   Abstract \u003e\u003e Marketing

   Countries The European Union the pharmaceutical market ... registration in ... in the CIS countries. States Central Asia includes ... drugs with low profitability. This fact significantly limits the ability to invest in elaboration innovative generics ...

5. The role of the pharmacist in ensuring the operation of the pharmacy

   Coursework \u003e\u003e Medicine, health

   New independent states... Guide developing and implementation ... about the existing synonyms and generics, price information ... drugs, and not direct sales, so pharmacists are in demand there in marketing, certification and registration ...

Samvel Grigoryan on the complex "relationship" between original drugs and generics

The progress of mankind is ensured by the pioneers, and the development of the pharmaceutical industry - by the developers of new drugs and technologies for their production. Each of their discoveries is another hope for patients and another contribution to modern medical practice. Worldwide life expectancy has increased by more than 20 years since 1950, according to WHO. This unprecedented social impact is largely due to new drugs. It will not be an exaggeration to say that innovations have paved the way from incurability to curability, to greater effectiveness and safety of treatment.

Hot on the trail: original drugs and their copies

It's always harder to be a pioneer. The development of original (innovative) medicines is a science-intensive, long-term process that requires large intellectual, financial and organizational resources. Hundreds of millions of dollars spent on obtaining a new pharmaceutical substance determine the high cost of the drug created on its basis. This is the price we all pay for the opportunity not only to have pharmaceutical science, but also to develop it.

The laws of the market cannot be abolished, and it is hardly possible to deprive other manufacturers of the right to repeat (of course, on legal grounds) the original drug and offer the consumer this “copy” (generic) under his trade name. In a word, competitors are ready to rush on the hot trail laid by innovative companies without delay. And not only to strive, but also to “overtake”, having achieved - due to the lower price - an advantage (sometimes quite significant) in sales volumes. Examples when a generic drug is bought more often than the original drug from which it was "copied" are known to every pioneer.

Rivalry between market participants is beneficial if competitors are placed on a level playing field. In this case, those following the trail have a huge advantage - they do not have to spend huge amounts of money to create a "new formula". And the funds are really big. For example, according to Yuri Mochalin, director of corporate relations and work with government agencies at AstraZeneca, the international biopharmaceutical company AstraZeneca annually invests more than $ 4 billion in research and development. Unencumbered generic companies can offer their product at a significantly lower price, and the market position of the respective originator product will inevitably suffer from unequal competition.

If the products of innovative companies cease to pay off and become low-profit, this will lead to curtailment or slowdown of the already long process of developing novelties in pharmaceutical science. Such a prospect is disadvantageous not only to the creators of original medicines themselves, but also to patients, doctors, as well as - oddly enough - to formal competitors, generic companies, since in this case they will have nothing to reproduce.

Protective Measures: Patent Protection of Medicines

In order to avoid this, it is necessary to compensate innovative companies for unequal conditions of existence in the market. This can be done by one of the tools of patent law - the prohibition of reproduction of the original formula for the period established by law. Thanks to him, the owner of a patent for a new drug temporarily gets rid of the obviously unequal competition. This exceptional measure gives innovative companies the opportunity to recoup their drug development costs and generate the profits needed to further invest in drug development.

The duration of this compensatory privilege of the copyright holder in our country, in accordance with paragraph 1. of Art. 1363 of the Civil Code is 20 years old. The countdown goes, of course, not from the moment the drug appeared on the market, but from the date of filing the initial application for a patent. But from the beginning of the development of the original formula to its "premiere" sometimes it takes up to 10-15 years. Thus, in practice, innovative companies do not enjoy the benefits of patent protection as long as it seems at first glance. At the same time, manufacturers, as a rule, strive to warm up interest in their new brand in advance, so that the “premiere” of the drug on the market is immediately marked by a high level of sales.

The United States has a 12-year patent protection period for drugs of biological origin and a 20-year period for drugs obtained by chemical synthesis. In the countries of the European Union, the term of the patent can be extended to 25 years.

Another form of intellectual property protection in the field of pharmaceutical inventions is the exclusivity of research data from the developer company. Russia's recent accession to the WTO (23 August 2012) marks the entry into force of a new rule. Commenting on her, Vladimir Shipkov, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM) , notes that now, within 6 years from the moment of registration of the original drug, no other company can use the results of its preclinical and clinical studies to market its (reproduced) product. True, according to Yuri Mochalin, director for corporate relations and work with government bodies of the company AstraZeneca (part of the Association), this provision of the federal law does not yet have by-laws and therefore has not yet been applied. The Ministry of Health and Social Development is currently working on writing such acts, and the Association takes an active part in this work in order to make the data exclusivity rule alive.

It is clear that the first, almost instinctive desire of any buyer is to purchase a medicine as cheaply as possible. Therefore, it would seem that such a formally “protectionist” measure as patent protection is not beneficial to him. But this is only at first glance. The consumer, who is also the patient, is indirectly interested in the continuation of pharmaceutical research, the appearance on the market and the immediate introduction of new generations of drugs into medical practice - more and more effective, safe, selectively acting. By “overpaying” for the brand, he cares (in the overwhelming majority of cases unconsciously) about his future, about the day when some medicine, not yet created, will help him, his children, grandchildren, maybe even save them.

Moreover, the “drug portfolio” of many innovative companies contains orphan drugs that take a long time to pay off and do not bring much profit. Their development and production are a consequence of the awareness of responsibility to each patient individually. Competitive companies rarely show interest in the reproduction of drugs for the treatment of rare diseases. It turns out that patent law is a tool to protect not only innovative companies, their investments in pharmaceutical research, but also the vital long-term interests of the consumer.

Competitive “symbiosis”: the role of generics in the development of the pharmaceutical market

On the other hand, a reasonable limitation of the patent protection period protects both industry participants and patients from the unjustifiably prolonged monopoly of the copyright holder. This is the meaning and benefit of the presence of generic companies on the market: they form a competitive environment in the pharmaceutical sector, the presence of which is in the interests of the consumer.

Generic drug manufacturers, as a rule, prepare in advance for that momentous day when the copyright holder loses his exclusive right. Their activity is especially great when it comes to a widely demanded drug. Legal “copies” usually appear on the market almost immediately after patent protection expires. Two or more trade names containing the same pharmaceutical substance begin to compete, the market for this drug (previously entirely owned by the original) is divided between the competitors, and this can lead to a drop - sometimes quite significant - in sales of the more expensive original drug.

And yet, it is wrong to reduce the relationship between innovative and generic companies solely to competition. Both parties need each other to some extent, and the consumer of their products needs healthy competition between them. Generic manufacturers, as noted above, have a vested interest in developing innovation in order to have something to reproduce.

The benefit of the creators of original drugs from the well-being of their competitors is less obvious, but it should be borne in mind that the lack of competition always affects the market and its participants negatively. The realities of the pharmaceutical industry in the form of the inevitably approaching end of patent protection and ready-to-start generic companies do not allow original manufacturers to relax and lose the momentum of new developments, resting on the laurels of previous achievements. This competitive “symbiosis” is doubly beneficial to the consumer. He has the opportunity to choose, taking into account a combination of factors such as the quality and brand of the drug, the appointment or recommendation of the doctor, the advice of a pharmaceutical worker, the patient's habit of a specific name, "which helps him", the price of the drug.

Choice and statistics

The ranking of these factors in order of importance in our country strongly depends on geography. In Moscow and other large cities, brands are preferred more often, especially if they are advised by pharmaceutical workers. A consumer's attachment to a particular pharmacy or pharmacy chain, that is, a pharmacy brand, often implies his trust in the recommendations of the top-ranked consumers and the products they offer. For shoppers with limited means, wherever they live, price is usually key.

One of the factors listed above still stands apart and claims to be a relative palm. It is about a doctor's appointment. Most of the patients are not well aware of such professional matters as "original drug", "generic", do not really understand what "analog" is. Even specialists sometimes have to remember which of the drugs of the same INN is the original, and which ones are its “copies” (especially when it comes to the names that have been on the market for more than a decade).

Buyers, as a rule, ask at the pharmacy for the trade name prescribed (recommended) by the doctor and which is printed on the package in large letters. On another name, which is displayed in small print (INN), the mass consumer usually does not focus attention. Thus, in many cases of outpatient treatment, and especially in hospital practice, the choice between the original drug and the generic drug is made by a medical professional.

The realized preferences of consumers, healthcare workers, healthcare organizers together form statistics. According to the DSM Group marketing agency, in value terms, the share of original drugs (drugs that are protected by a patent or have been protected by a patent, that is, the first in the INN) on the Russian pharmaceutical market has not changed significantly over the past 3 years and is approximately 41%. In volume terms, the share of originals is much lower - about 12%. Of course, this is due to the fact that they are more expensive than generics. At the same time, again according to DSM Group data, the average cost of an original drug is about 500 rubles, while a generic one is about 100 rubles. DSM Group predicts that there will be no significant reallocation of market shares in favor of generic drugs this year and next. A wave of changes is possible after 2014, when many original drugs will be released from patent protection.

Generic brand

There are different trends in the global generics sector. Many preparations of generic drugs, of course, cannot be fully (therapeutically, pharmacologically) considered equivalent to their originals. But there are many examples of the opposite. The product quality of the leaders of the generic sector is high enough for the name of these companies to be perceived as a brand.

In addition, in an effort to add additional sustainability to their businesses, some innovative companies are diversifying their activities by creating and developing a generic business. A good example is Sandoz, a generic division of the Novartis group of companies. That is, the market for drugs based on generic drugs is heterogeneous, and from it one can distinguish a segment of “branded” generics provided with the brand and quality of technologies from leading manufacturers. It follows from this that the reality of the pharmaceutical industry is not only competition between original drugs and their “analogues”, but also a price “war” in the generic sector, usually driven by those market participants whose products can be called “non-branded”.

If this process acquires a “dumping” character, then the knowledge-intensive pharmaceutical industry, unlike many other areas of the economy, suffers rather than benefits from such trends. Each unit of profit lost by those who invest it in the research base, new developments, improvement of the production of original drugs and high-quality generics, turns into a slowdown in the pace of development of the innovative and technological potential of pharmaceutical science and industry. But limiting these trends or introducing lower price thresholds is hardly possible.

Balance and perspective

Innovative companies are not the only ones diversifying their activities. The policies of some leaders in the generic sector show a more or less pronounced turn towards the development of research and development, development and acquisition of know-how. Rustam Iksanov, vice-president for strategic development of Akrikhin, draws attention to the fact that all manufacturers have to solve the question: how to maintain growth when the number of “new formulas” in the world is decreasing from year to year. That is why Akrikhin directs its efforts to create so-called “generic plus” products, that is, generics with added value (generics with signs of originality). In this case, of course, it should be borne in mind that a generic company cannot transform into an originator, these are fundamentally different business models

Alexey Kovalev, sales director of the pharmaceutical company "Vertex", sees the prospect in relying on innovation, production of know-how, drugs with elements of originality. This will ensure the stable existence of the company, strengthen its position in the market and create a manageable part of the assortment, free from the influence of external factors and the economic situation. Other priority measures, according to Aleksey Kovalev, are tracking the validity periods of patents for original drugs and the production of generic brands. Compared to non-branded ones, they have a longer life cycle and a higher price. It remains stable for a long time and even grows. Among the measures contributing to the successful promotion of generic brands, Alexey Kovalev means increasing consumer awareness of this class of medicinal products.

However, not all manufacturers consider it possible and advisable to develop both directions. As noted by Yuri Mochalin, director of corporate relations and work with government agencies at AstraZeneca, there are industry participants who decide not to diversify their activities, and AstraZeneca belongs to them. It looks quite attractive to have its own generic division, which would allow using new opportunities. Nevertheless, AstraZeneca adheres to its strategic decision to remain in the innovation sector. This decision was made after the merger of the two companies Astra and Zeneca in 1999, and it has not changed since then. “We do not expect any deviations in the global strategy,” concludes Yuri Mochalin.

As shown by the above data of the marketing agency DSM Group, the ratio of the market shares of originals and generics in recent years is quite stable. Time will tell whether Russia's recent accession to the WTO is capable of influencing this peculiar balance. So far, there are not enough grounds for a positive answer to this question. The introduction of the drug insurance system may affect the ratio of originator drugs to generics. This is a separate big question, depending on which of the models of this social security mechanism will be taken as a basis in our country.

Generic (English generic, reproduced medicine) is a copy medicine that coincides with the original in terms of the amount of active substance and the effect on the body.

When a new drug is invented, it is researched and tested for a long time, and then a patent is issued. When a patent expires, other companies can also produce similar generic drugs. But in Russia the rights of patent holders are often violated On the problems of intellectual property in the drug market, and generics are registered and sold before the patent for the original drug expires.

Do generics have complicated names?

Not necessary. Each drug has several names: chemical, international non-proprietary name (INN), and trade name.

A chemical name is an unpronounceable phrase that doesn't tell you anything. INN is a unique name for an active substance, which is approved by WHO and must be indicated on the packaging of the drug.

In addition, the drug manufacturer can assign a trade name to its product, which will be written on the package in large letters.

• Chemical name: 2- (2- (2,6-Dichlorophenylamino) phenyl) acetic acid (as sodium salt).
• INN: diclofenac.
• Trade names: "Voltaren", "Vourdon", "Diklak", "Dikloberl", "Olfen", "Ortofen" and many others.

Why do people prefer generics?

Because they are much cheaper. Before a new drug is patented, manufacturers spend a lot of money on developing and testing it, and this affects the final cost. The generic registration procedure is much easier and faster. This explains their cheapness.

And no research is being done?

According to law Art. 18 of the Federal Law of 12.04.2010 N 61-FZ (as amended on 28.12.2017) "On the Circulation of Medicines" to register a generic drug, instead of a report on own preclinical studies, you can provide an overview of scientific papers on the results of preclinical studies of a reproducible drug, and instead of a report on your own clinical studies, a report on the results of bioequivalence studies of a reproduced drug.

Bioequivalence indicates the extent and rate of absorption, the time to reach maximum concentration in the blood, distribution in tissues and body fluids, and the rate of elimination.

So studies proving the efficacy and safety of the new generic drug are still being conducted, but they are not as long-term and expensive as in the case of the original drug.

And are there many generics on the market?

According to the report Russian pharmaceutical market, December 2017 analytical company DSM Group, in 2017 there were 86.2% of generics in the Russian market. And this is 0.5% more than in 2016.

20.1% of all sold generics are drugs that affect the digestive tract and, 14.2% are drugs for the treatment of diseases of the nervous system, 14.0% are drugs for the treatment of diseases of the cardiovascular system.

What about their effectiveness?

Study Generic statins: is it that simple with proof of clinical equivalence? 2012 showed that out of four generics of simvastatin (drugs to lower blood cholesterol), only two fully comply with the original in terms of safety and effectiveness.

And in 2013 it turned out Safety and efficacy of generic drugs with respect to brand formulation, that due to the reduced effectiveness, generics can increase the duration of treatment or even completely. On the other hand, if the dose of the medicine is increased to speed up the treatment, negative effects can be caused.

It turns out to be a real lottery: some generics are as effective and safe as the originals, while others can prolong the treatment and cause side effects.

Why generics might be less effective?

The effectiveness of the drug is influenced by many factors, including the degree of purification of the active substance and additional components that may contain generics. If a company buys a cheap active ingredient, the generic drug may not be effective enough. And additional components can cause or side effects.

How to distinguish a quality generic?

First of all, you can focus on the price. If a drug is very cheap, even in comparison with other generics, its manufacturer has clearly saved on something. For example, on the quality of the active substance or on the control during production.

Good indicator of product quality: pharmaceutical production has a GMP (Good Manufacturing Practice) certificate. If a company has such a certificate, it means that its products were produced under the required conditions (purity, temperature, humidity), excess substances do not get into the medicine, it is packaged properly and retains all its properties.

Should you use generics?

Considering the share of generics in the Russian market, we can say that we have all been treated with such drugs and there is nothing wrong with that. Generics make treatment affordable for anyone of any income and provide therapeutic benefits and relative safety.

When writing out a prescription, the doctor indicates the name of the active substance, so you can independently choose a specific generic or original drug (a list of original drugs and their generics can be found). Often the doctor advises a proven generic, in which case it is better to use it. If the drug gives side effects, you need to consult your doctor: perhaps he will prescribe a more expensive generic or original drug.

More than 80% of drugs sold in Russia are generics. The popularity of generics is understandable: in most cases, they are cheaper than original drugs. Manufacturers do not spend money on their own long-term research, but copy existing drugs. But copying is not completely, but with slight deviations. And these deviations are cause for concern. In this article, we will talk about the problems of using generics and attempts to overcome these problems.

Generics: risk factors

Let's figure out what is the risk of using generics by patients:

• the original and the generic have the same active ingredient, but the excipients, the degree of purification and the methods of assimilation in the body may differ. For example, the original can be sold in pills, and the generic in capsules: they will be absorbed in different ways. In this regard, treatment with generics is of concern to doctors.

To register a generic drug, it is enough to show the content of 80-120% of the active ingredient in comparison with the original drug. An amplitude of 20% can be dangerous, especially in highly potent drugs such as those used to treat cancer.

• insufficient control over the production of generics. According to the Law on Circulation of Medicines, for registration of a generic drug, instead of a report on one's own preclinical studies, one can provide an overview of scientific papers on the results of studies of a reproducible drug, and instead of a report on one's own clinical studies, a report on the results of bioequivalence studies of an original drug. At the same time, the legislation does not require the therapeutic equivalence of the generic - the efficacy and safety equal to the original.

loss of medical control over the treatment process. By order of the Ministry of Health, doctors are required to prescribe to patients the international nonproprietary name (INN) of the drug, and not the trade names. The patient brings a prescription with INN to the pharmacy, and the pharmacist offers drugs with a suitable substance: originals or generics. The buyer chooses at his own discretion. Since the effectiveness of drugs is different, generic treatment becomes unpredictable.

On the one hand, generics help patients and the government save money, on the other hand, they can reduce the effectiveness of treatment.

Import substitution in the generics market

At the end of 2018, in price terms, 30% of the drugs sold were domestically produced. And the share of Russian medicines in the list of vital and essential medicines is 80%.

EXPERT SPEAKS

“The Russian market of pharmaceuticals mainly consists of generics: 85.6% of packs are in this segment. Moreover, more than 52% of them are non-branded generics and only 33% are branded.

This picture is due to the fact that the Russian pharmaceutical market mostly consumes cheap drugs - 40% of the market falls on drugs under 50 rubles. The average cost of a pack on the pharmaceutical market for 9 months of 2018 is 224 rubles. Original ones cost 600 rubles, generics - 161 rubles.

Generics are mostly represented by domestic drugs: 46% in rubles and 73% in units. Original drugs are mostly imported: 87% in rubles and 83% in packages.

Many foreign companies localize the production of original drugs and branded generics in order to participate in government procurement. "

The state's desire for import substitution is understandable: to reduce costs and dependence on foreign suppliers. Another question is whether Russian pharmaceutical manufacturers are able to satisfy the state's demands by ensuring the proper quality.

Director of the Rassvet clinic, gastroenterologist, Ph.D. Alexei Paramonov is confident that now Russian pharmaceutical manufacturers will have to make up for a long time in technical lag in order to reproduce complex biological products: antibodies, recombinant proteins and drugs for targeted therapy of cancer. If such drugs are not imported, oncology and rheumatology will suffer - the death rate of patients will increase.

Branches of foreign manufacturers are ready to produce high-quality generics in Russia, but they often lose the price war - both in pharmacies and in public procurement.

EXPERT SPEAKS

Mikhail Salikhov, Marketing Director of EGIS-RUS, the company supplies the Russian market with preparations of the Hungarian manufacturer "EGIS"

Generics will undoubtedly increase their market share, primarily due to their affordability compared to original drugs. The growth of this segment will be driven by both an increase in consumer demand in retail and purchases under various government programs.

At the same time, the problem of the quality of various analogs remains relevant. As much medical practice shows, it can vary greatly from one drug / manufacturer to another. The choice of a generic drug only on the basis of the criterion of "minimum cost" may be at best useless and ineffective in treating the disease (and this is lost time and the risk of complications), and at worst - cause damage to human health.

As for public procurement, in them the criterion of "generic quality" should ultimately be taken into account in one form or another (the level of biological, or better - therapeutic equivalence to the original drug). Now only the price is taken into account.

Sometimes import substitution of a drug has a detrimental effect on patients. For example, a twenty-year-old girl from Sterlitamak had a severe deterioration in her health after replacing an imported drug with a domestic generic. The girl has a heart defect and high pulmonary hypertension. Since 2012, the Ministry of Health has provided her with the imported drug Tractlir. And in the spring of 2018, Tracleer was replaced by the Russian generic Bosenex, which led to a sharp deterioration in his condition. If the Ministry of Health does not renew the provision of Traklir, the girl may die.

On the Change.org portal, petitions are being created asking not to replace original drugs with generics, because this worsens the condition of patients.

Obviously, problems with the quality of generics need to be addressed at the state level: change laws and tighten control. The government plans to deal with just such tasks in the near future.

The future of generics is control and standardization

In the near future, the pharmaceutical market expects three types of standardization: standardization of prices for the VED list, mandatory labeling and a new procedure for putting drugs on sale.

From 2019, manufacturers will be obliged to limit prices for drugs from the VED list - this is about 800 drugs. This will also affect generics. Generic prices will decline if the price of the originator drug or its other generics decreases. At the same time, drug prices will be monitored not only in Russia, but also in 12 reference countries. The Ministry of Health is confident that such measures will reduce the cost of providing drugs to patients and that medicines from the VED list will become cheaper in pharmacies.

Most likely, artificial price caps will have a detrimental effect on producers and consumers. Producers will incur costs in three areas at once. They will have to give up some of the profits by lowering prices. We'll have to re-register the current prices. And constantly monitor changes in drug prices in several countries at once.

READ ALSO:

• Can a doctor refuse a patient: legality, consequences, recommendations
• New medical technologies and trends: what health care will face in the next 5 years
• Clinical practice guidelines: what the new law will bring to leaders and healthcare professionals

Due to the loss of profitability, some manufacturers and drugs will leave the Russian market - the range of drugs in pharmacies will be reduced. To compensate for the shortfall in income, manufacturers will raise prices for drugs that are not on the VED list - again a blow to the consumer.

Mandatory drug labeling will overtake the pharmaceutical market in 2020. Each drug sold in Russia will be entered into a single monitoring database. And on each package a special code will appear, by which you can check the composition and manufacturer. So the government plans to fight counterfeits and low-quality drugs. However, tighter controls could drive up prices. Mandatory labeling is an additional cost for manufacturers. These costs will be included in the cost of the product.

At the end of November, a new procedure for the import and registration of medicines, including generics, will be launched. Distributors will be obliged to provide Roszdravnadzor with manufacturer certificates and confirm the compliance of drugs with the requirements established during their registration. New drugs, first produced or imported into the Russian Federation, will be required to test protocols. Drugs without the appropriate "accreditation" will be seized before the submission of permits.

How to check the quality of a generic

At the moment, doctors have two ways to check: check drugs in the database of the supervisory authority and see consumer reviews.

You will find a large database of drugs on the website of the Federal Service for Surveillance in Healthcare (Roszdravnadzor). The doctor has access to information from 13 sources:

To keep abreast of the latest data on the quality of drugs, you will have to constantly monitor newsletters:

For citation:Generics on the Russian pharmaceutical market // RMZh. 2001. No. 24. S. 1118

The last decade of the twentieth century on the Russian pharmaceutical market was characterized by an avalanche-like increase in the number of modern original medicines and their numerous analogues produced by various pharmaceutical companies under different trade names. Prices for these drugs vary considerably. If you ask the average patient in a pharmacy or clinic what medicine he would like to be treated with, then it is reasonable to assume that, without going into the details of their differences, he will prefer drugs that are significantly lower in price. In Russia, the problem of choosing drugs remains acute also because there is a shortage of modern Russian analogues of foreign-made drugs and doctors do not have information about the possible replacement of expensive drugs with high-quality domestic generics. A poll conducted by the Russian company ZAO Veropharm among doctors in Moscow and Yaroslavl showed that 70% of them cannot explain the difference between a generic and an original drug. An original drug is a firstly synthesized drug that has gone through a full cycle of all experimental and clinical studies, a synthesis method, and often a chemical formula of an active ingredient of which is protected by a patent for a certain period. The company that was the first to synthesize a new chemical that can be used as a drug receives the exclusive right to manufacture and sell it. The duration of a patent protected right is usually 20 years. Upon expiration of the patent protection period, any pharmaceutical company certified in accordance with the necessary requirements receives the right to manufacture its own drug. The active ingredient is the same substance. In fact, it will no longer be an original, but a reproduced drug - a generic. So what are generics? According to the definition given by the European Federation of Associations of Pharmaceutical Manufacturers, generics are generic drugs, interchangeable with their proprietary counterparts, introduced (sold) to the market after the expiration of the patent protection period for the corresponding patent protected drug. Generics copy original drugs that have expired and are manufactured in strict accordance with existing legal regulations and quality standards. The creation of generics is significantly less expensive compared to the original drug. Therefore, the generic is always much cheaper. So, in particular, the average retail price of high-quality generics of Russian ZAO Veropharm does not amount to several tens of rubles, which is several times cheaper than original drugs. One of the most important components of the generic production of this company, focused on the production of really high-quality drugs that are in no way inferior to the original “prototypes” of drugs (except for the price), is compliance with the international Good Manufacturing Practice (GMP) standards. In addition, Standard Operating Procedures have been developed in accordance with GMP standards, the presence of which is a mandatory part of these standards. From the point of view of clinical practice, the physician must be sure that replacing one drug with another will not harm the patient, i.e. the drugs to be replaced must be therapeutically equivalent. This is the main property of a high-quality generic and is achieved by quality control of the manufactured drug. Thus, quality control at one of the leading Russian enterprises, ZAO Veropharm, is carried out at each of the seven stages of production: at the stage of validating raw material suppliers; incoming quality control of supplied raw materials; production that meets GMP standards; quality control of the finished medicinal product; control in specialized state bodies; verification by an independent laboratory; and, finally, at the stage of clinical trials in clinics and institutes of the country. To carry out such tests, the company cooperates with the most famous and reputable organizations and clinical centers in their field. This is the State Research Center for Preventive Medicine of the Ministry of Health of the Russian Federation, the Research Institute of Pediatric Hematology of the Ministry of Health of the Russian Federation, the I.M. Sechenov, St. Petersburg State Museum of Fine Arts named after I.P. Pavlova and others. The program for the production and development of generics provides not only the search and introduction into production of certain promising drugs, but also the implementation of full-scale marketing activities. Because a significant part of the generic assortment produced today is prescription drugs, and their successful promotion is possible only if there is an effectively operating network of medical representatives. This is all the more important because most generics are still little known to a wide range of doctors in Russia. Hence, it seems obvious that Russian companies are striving to expand the range of manufactured drugs, both at the expense of the most widespread in the world market, and by creating the so-called. "Therapeutic portfolios". This refers to the formation of groups of drugs, each of which is used in the practice of a doctor of a certain specialty. These portfolios include most of the most advanced funds currently registered in Russia. In this regard, ZAO Veropharm takes a leading position. The company produces more than forty generic brands belonging to ten pharmaceutical groups. Among the latter are cardiological, antimicrobial, oncolytic, agents for the treatment of diseases of the gastrointestinal tract, and others. Thus, summarizing the above, the advantages of generics in the pharmaceutical market are that: prices of generics are always significantly lower than original drugs, which means that they are more affordable for all categories of patients, especially those with low and middle income; generics allow doctors to strive to “treat everyone and well” even in economically underdeveloped countries, using the most modern generics of expensive original drugs in their practice; generics are well studied in terms of efficacy and safety, provide a choice for the doctor and the patient; The “pressure” of generics on the market is one of the factors forcing companies that manufacture original drugs to more actively introduce new promising developments. The use of generics in clinical practice is an alternative and economic necessity for full-fledged drug provision for the Russian population with low and middle income. The material was prepared by Ph.D. N.G. Lyutov