In 2014, the growth rate of the Russian pharmaceutical market will be at the level of 3-6%, then the market will grow and develop steadily, which will allow the economy in general and the pharmaceutical industry in particular to recover. According to the rating, by 2018 Russia will be among the ten largest pharmaceutical manufacturers. How will the pharmaceutical industry grow, what are the prospects for the development of the market for reproduced generic medicines, and how proven is their effectiveness and quality? These issues were discussed during the round table “Generic Medicines: Challenges and Prospects” at the International Conference “Quality of Medicines and Medical Products”, held in Moscow under the auspices of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) at the end of May. G.
THERE IS A STRONG GROWTH TREND IN THE GENERIC DRUGS MARKET IN RUSSIA
Denisova Maria Nikolaevna
Leading manager of IMS Health, Doctor of Pharm.D.
What is driving the growth of the global pharmaceutical industry, and who is driving it? The undisputed leader is the United States (60%), there is a temporary lull in the European pharmaceutical market, the growth rate for the main powers in the European market is just over 2%. The traders include a segment of countries with fast-growing economies, to which Russia belongs, and according to our forecasts, this segment will increase at the level of 9-12% in the next five years.
According to the rating, by 2018 Russia will be among the top ten largest pharmaceutical manufacturers also because the Russian market is the most attractive among all pharmaceutical markets in Eastern Europe. If you look at the ranking of pharmaceutical companies in the prescription segment, the leaders here are Novartis pharm, Roche, Sanofi Aventis, Gedeon Richter, KRKA pharma. At the same time, there is an increase in the level of drug consumption by the Russian population. Compared to the countries of the European Union, we consume prescription drugs in a different price aspect.
If you look at the structure of costs in healthcare and take the segment of countries with sustainable developed economies as a starting point, you can identify the following leaders: the USA, Japan, five European countries and the UK. Their expenses, incl. and for drug provision, amount to about 19%. In rapidly growing countries, the cost of drug supply is about 30%; this record is explained by the lack of money for the stable development of the pharmaceutical industry, so the above countries are striving to reduce the cost of drug supply. This happens by regulating the range of medicines at the state level.
Generic drug production will increase due to sponsorship from insurance and private companies. The Eastern European market currently offers generics, branded (sold under their trade names) and unbranded (sold under their international nonproprietary names). Branded generics dominate in Eastern European countries.
What about in Russia? Our country ranks 113th in the world in terms of healthcare costs per capita, and 130th in terms of efficiency of spending budget funds. Annual costs for the development of the pharmaceutical industry amount to 650 billion rubles. Some of the generics consumed by the Russian population are without patent support (according to research, up to 49%), unbranded ones make up 19%. Today, on the Russian pharmaceutical market, the share of protected generics (with a patent) is 65%, and those with an unrenewed patent are 35%.
Over the past 5 years, there has been a consistent trend toward an increase in the share of generics; Thus, in 2008, the share of branded generics was 71%, unbranded - 17%, in 2013 - 74 and 19%, respectively. Let me assume that the share of unbranded generics will increase even with the advent of insurance medicine, which is explained by their relative cheapness. The state wants to save on drug supplies, which will undoubtedly affect both the income of manufacturers and the health of patients.
QUALITY OF ORIGINAL AND REPRODUCED DRUGS: THE SCORE IS EQUAL
Dubinin Konstantin Viktorovich
Director for interaction with government agencies and corporate policy of JSC Teva
According to experts from the World Health Organization (WHO), not a single country has sufficient funds for drug supply, therefore, in order to reduce the cost of pharmacotherapy, WHO and other international organizations recommend implementing generic substitutions in medical policy. Today, in the ever-growing generic market, the consumer expects to see evidence of the effectiveness and compliance with the quality of the generic drug (GMP) - the generic and the original drug. This raises the question: how do generics differ from original medicines (OLM)?
If we evaluate generics and generic drugs by quality and effectiveness of use, then the answer is clear: nothing. A generic is a reproduced innovative drug for which the patent protection period has expired. The generic has the same composition of active ingredients and a similar dosage form as the OLS. Generics benefit from OLS in terms of price, because their cost is significantly lower. Manufacturers of VLS do not incur costs for the development and testing of drugs; they copy the chemical formula, so the production of generics is cheaper. It has been established that 50% of ODS manufacturers are engaged in the production of generics.
To obtain permission to market a particular drug in a particular country, the manufacturer must provide data on the bioequivalence of the generic drug in relation to its branded analogue. In addition, VLS manufacturers invest 6 to 16% of their revenues in research and development activities to ensure the quality, safety and effectiveness of their products. Manufacturers of generic drugs conduct independent research and develop their own formulations, since the EML data is not disclosed to third parties. Like brand-name drugs, generics are produced in factories that meet Good Manufacturing Practice (GMP) standards and are periodically inspected by patent organizations. Practice has shown that the use of generics contributes to the full supply of medicines to the population with low and middle incomes. VLS provide a choice for the doctor and the patient.
In connection with the speedy transition to international GMP standards, it is necessary to ensure accurate reproduction of the EML, which guarantees the quality of the generic at the stage of its creation. GMP standards guarantee, for both OLS and VLS, responsible handling of raw materials, including excipients, and competition at every stage of the life cycle. All that I have stated allows me to conclude: in terms of their pharmacological properties, generics can replace OLS.
THERE IS NO UNIFORM APPROACH TO PATENT RIGHTS FOR GENERIC DRUGS
Zalesov Alexander Vladimirovich
Deputy General Director, Head of Legal Service of Soyuzpatent LLC
Russian patent legislation is in full compliance with international standards, incl. and on trade aspects. At the same time, Russian legislation and judicial practice are quite different when it comes to the area regulating the circulation of pharmaceutical products. In particular, in Russia there is almost no regulatory procedure that guarantees the entry of VLS into the pharmaceutical market, so that the legitimate interests of the patent holder are taken into account. Hence the conflict between VLS and OLS. There is a provision in the law that allows registration to be canceled if the distribution of certain drugs was considered a failure. You can apply for registration of a generic medicinal product only after the patent has expired. In Russia, it is easy to exercise your patent rights, and therefore the legitimate interests of the patent holder will be respected, but illegal ones will not be satisfied.
Registration of a pharmaceutical drug is a long process that begins with manufacturing and research, during which industrial batches are produced, the technological process for drug production is being developed, serious preclinical, pharmacological and toxicological clinical studies are carried out, and a large number of documents are drawn up. At the same time, a ban on registration of a drug containing a patented invention is an additional guarantee against patent infringement. Its absence opens up wide scope for abuse in the drug market.
Any patent holder strives to ensure that the term of his patent lasts as long as possible. To obtain a primary patent, registration of a molecule of the active substance is typical; for its application, it is important to prove that there is a proven method for its synthesis, and to obtain a preliminary assessment of its activity. The primary patent has a validity period of 20 years. It may be extended if registration took more than 5 years. It is known that the cancellation of the state registration of a VLS does not entail the automatic cancellation of the decision to extend the validity of the patent. An application for extension of the patent term may be received after the main 20-year validity period of the patent has expired and will be considered if the patent was still valid at the time of receipt.
Abuse of a patent in international practice, according to the Paris Convention for the Protection of the Rights of the Patent Holder, is prohibited and entails its cancellation. Patent abuse can be considered an illegal monopoly or a violation of the rules of healthy competition. To ensure a timely response to the case of patent abuse, the patent holder should carry out constant monitoring and promptly notify the relevant authorities of the extension of the patent term.
ABOUT THE TERMS OF PROTECTION OF PRE-CLINICAL AND CLINICAL STUDIES
Plieva Madina Robertovna
Director of Legal Affairs of the Association of International Pharmaceutical Manufacturers (AIPM)
WTO protection affects, among other things: Agreement on the Protection of Intellectual Property Rights (TRIPS), the provisions of which are already partially reflected in Russian legislation. The protection of preclinical and clinical research data, which is equated to intellectual property, is subject to Federal Law No. 323-FZ “On the fundamentals of protecting the health of citizens of the Russian Federation.” According to this document, a number of regulations prohibit the registration of generics within 6 years from the date of registration of the original drug, citing data from preclinical and clinical studies of the reference drug.
In EU countries, the protection period for data from preclinical and clinical studies is 10 years. The period consists of 8 years, during which it is impossible to submit an application for registration of a drug, and during the next 2 years it is impossible to bring the drug to the market. If a new drug is used in pediatrics, then 5 years are added to the time it takes to bring the drug to market. In the USA, for small-molecule drugs, the period of data protection for preclinical and clinical studies with subsequent procedures is 5 years, it increases for drugs used in pediatric practice. For biological products, the time period for bringing them to market is 12 years. In Canada, a similar period of validity lasts 8 years, of which 6 years the drug cannot be registered and introduced into the pharmaceutical market.
For more successful competition between generics and VLS, the state can adjust the terms of drug protection, which is quite feasible in accordance with Federal Law No. 61-FZ “On the Circulation of Medicines,” which provides for transition points from research to practice. Probably, the terms of protection of data from preclinical and clinical studies for 4 years for chemical products, and up to 3 years for biological products, can be considered more optimal. Guarantees of such protection will help increase the investment attractiveness of the Russian market for leading foreign pharmaceutical companies and will make their work in Russia more predictable. Data protection will provide an additional incentive for costly research to develop innovative medicines.
The German concern STADA AG is the founder of the mass production of generics. The company has been producing generic drugs around the world for more than 120 years. One of the company's priorities is to make effective and safe drugs more accessible to patients.
Today STADA is the leader in the production of INN generics in Russia*. The company's generics have the lowest average price per pack among the TOP 15 pharmaceutical corporations.
STADA's product portfolio in Russia includes 175 types of medicines of various ATC classes and release forms produced by leading Russian and international pharmaceutical companies - NIZHFARM, STADA AG, Hemofarm A.D and Grünenthal.
When forming its portfolio, STADA gives priority attention to drugs in such socially important areas of medicine as cardiology, neurology, gynecology, urology and others.
Every year the Russian portfolio is replenished with an average of 10 new products. Employees of the STADA PharmDevelopment (R&D) division are constantly working to improve drug formulas, find new ways to deliver active ingredients and bring popular drugs to the Russian market. The company's product portfolio corresponds 90% to the structure of pharmacy demand.
*according to IMS Health
Diversified product portfolio
MHH generics
Traditional preparations
Brand generics
Medical products
FAQ
What are generics?
Generic drugs are drugs with the same active substance as in the original supplier's product and with the same therapeutic effect, which, after the expiration of the patent or other industrial property rights, can be offered at a significantly lower price.
What is a patent?
A patent is a set of exclusive rights granted to an inventor for a limited period of time in exchange for the unveiling of a new product. In the pharmaceutical industry, a patent allows a drug to be sold only to the company that developed it. This period of exclusivity allows the patent holder to recoup his costs of developing and creating the original drug and make a reasonable profit. Once the patent expires, it becomes possible to legally produce generic versions of the original drug. You can patent the formula of a generic drug, but not its active ingredients.
What is the validity period of a patent for original medicines?
20 years for a standard patent - the same as in other industries. However, in both pharmaceutical and other industries in the European Union, patents can be renewed for a further five years upon receipt of a Supplementary Protection Certificate (SPC).
What is INN?
International nonproprietary name (INN) is the unique name of the active substance of a drug, recommended by the World Health Organization (WHO).
The INN is fundamentally assigned only to single, clearly identifiable substances that can be unambiguously characterized by chemical nomenclature (or formula). The process of selecting an INN takes a long time (on average 26.4 months). All selected names are published by WHO upon notification to the requester in the journal WHO Drug Information. Since 1997, as a rule, two lists of recommended and two lists of suggested names have been published per year; these lists are compiled in three languages: English, French and Spanish, and also include the Latin version of each international nonproprietary name.
A complete list of INNs is also published, which is updated regularly. It lists INN names in Latin, English, French, Spanish, Arabic, Chinese and Russian, as well as other common names for the same substances. As of 2010, more than 8,000 international nonproprietary names have been published.
What are INN generics and branded generics?
Generics are sold under an international nonproprietary name (INN generics) or under a proprietary name (brand generics), which differs from the brand name of the drug developer.
Why are generics cheaper than original drugs?
Do the quality and effectiveness of generic drugs differ from original drugs?
Generics have the same characteristics in terms of quality, effectiveness and safety as the original products. 50% of original drug manufacturers produce generics. They often make copies of their own original drugs, but sell them not under the trade/brand name, but under the international generic name, which corresponds to the name of the active chemical component in the drug. Generics and original drugs are distinguished only by price and appearance.
Generic drug manufacturers invest between 6% and 16% of revenues in research and development to ensure the quality, safety and effectiveness of their products. Since generics are manufactured in strict accordance with established regulations, they are just as safe and effective as the original drugs, but at the same time they are more affordable.
Where can I get information about generics?
One of the most authoritative sources with more detailed information about generics is the Generic Pharmaceutical Association website www.gphaonline.org
We also recommend that you use the state register of medicines located here: http://grls.rosminzdrav.ru/. If you want to inquire about any medicine, enter its name in the appropriate field. There you will see its trade name and international nonproprietary name. As you know, doctors are currently allowed to prescribe medicines only under the INN. By entering the INN in the appropriate line, you can view all trade names corresponding to this INN. There you can also find out information about the manufacturer of the medicine.
Samvel Grigoryan about the complex “relationships” between original drugs and generics
The progress of mankind is ensured by discoverers, and the development of the pharmaceutical industry is ensured by developers of new medicines and technologies for their production. Each of their discoveries is another hope for patients and another contribution to modern medical practice. According to WHO, since 1950, life expectancy at the global level has increased by more than 20 years. This unprecedented social impact has been achieved largely thanks to new drugs. It would not be an exaggeration to say that innovations have paved the way from incurability to treatability, to greater effectiveness and safety of treatment.
Hot on the trail: original drugs and their copies
Being a pioneer is always more difficult. The development of original (innovative) medicines is a knowledge-intensive, lengthy 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 to not only have pharmaceutical science, but to develop it.
Market laws cannot be abolished, and it is hardly possible to deprive other manufacturers of the right to repeat (legally, of course) the original drug and offer this “copy” (generic) to the consumer under their trade name. In a word, competitors are ready to rush on the “hot trail” laid by innovative companies without delay. And not only to rush, but also to “overtake”, having achieved - due to a 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 is “copied” are known to every pioneer.
Rivalry between market participants is a useful phenomenon if only competitors are placed on an equal footing. In this case, those following the trail have a gigantic advantage - they do not have to spend huge amounts of money on creating a “new formula”. And the funds are really large. For example, according to Yuri Mochalin, director of corporate relations and government affairs at AstraZeneca, the international biopharmaceutical company AstraZeneca annually invests more than $4 billion in research and development. Unencumbered by this level of costs, generic companies can offer their product at a significantly lower price, and the market position of the corresponding original drug will inevitably suffer from unequal competition.
If the products of innovative companies stop paying off and become low-profit, this will lead to a curtailment or slowdown of the already long process of developing new pharmaceutical science products. Such a prospect is disadvantageous not only to the creators of original medicines themselves, but also to patients, doctors, and also - 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. One of the tools of patent law allows this to be done - a ban on the reproduction of the original formula for a period established by law. Thanks to it, the holder of a patent for a new drug is temporarily freed from obviously unequal competition. This exceptional measure gives innovative companies the opportunity to recoup the costs of creating the drug and generate the profit necessary for further investment 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. The countdown, of course, does not start from the moment the drug appears on the market, but from the date of filing the initial patent application. But from the beginning of the development of the original formula to its “premiere”, sometimes up to 10-15 years pass. Thus, in practice, innovative companies do not enjoy the benefits of patent protection for 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.
In the United States, there is a 12-year patent protection period for drugs of biological origin and a 20-year term for drugs obtained by chemical synthesis. In the European Union, the validity period of a patent can be increased 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 (August 23, 2012) means the entry into force of a new norm. Commenting on it, Vladimir Shipkov, executive director of the Association of International Pharmaceutical Manufacturers (AIPM) , notes that now, for 6 years from the date of registration of the original drug, no other company can use the results of its preclinical and clinical studies to bring their (reproduced) product to the market. True, according to Yuri Mochalin, director of corporate relations and work with government agencies at AstraZeneca (part of the Association), this provision of the federal law does not yet have by-laws and therefore is not yet applied. The Ministry of Health and Social Development is currently working on writing such acts, and the Association is taking an active part in this work so that the rule on data exclusivity becomes alive.
It is clear that the first, almost instinctive desire of any buyer is to purchase medicine as cheaply as possible. Therefore, it would seem that he would not benefit from such a formally “protectionist” measure as patent protection. 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 into medical practice of new generations of medicines - increasingly effective, safe, selectively acting. By “overpaying” for the brand, he cares (in the vast 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 awareness of responsibility to each patient individually. Competing companies rarely show interest in reproducing medicines for the treatment of rare nosologies. It turns out that patent law is a tool for protecting not only innovative companies and 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 on the term of patent protection protects both industry participants and patients from an unjustifiably prolonged monopoly of the copyright holder. This is the meaning and benefit of the presence of generic companies on the market: they create a competitive environment in the drug sector, the presence of which is in the interests of the consumer.
Manufacturers of generic drugs, as a rule, prepare in advance for that significant day when the copyright holder loses its exclusive right. Their activity is especially great when it comes to a widely sought-after drug. The appearance of legal "copies" on the market usually occurs almost immediately after patent protection expires. Two or more trade names containing the same pharmaceutical substance begin to compete, the market for this medicinal product (previously entirely owned by the original) is distributed between the subjects of competition, 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 sides need each other to some extent, and the consumer of their products needs healthy competition between them. Manufacturers of generic drugs, as noted above, have a vested interest in developing innovations so that they have something to reproduce.
The benefit to the creators of original drugs from the well-being of their competitors is less obvious, but it should be taken into account that the lack of competition always has a negative impact on the market and its participants. The realities of the pharmaceutical industry in the form of the inevitably approaching expiration of patent protection and generic companies ready to launch do not allow original manufacturers to relax and lose the momentum of new developments, resting on the laurels of previous achievements. For the consumer, this competitive “symbiosis” is doubly beneficial. He has the opportunity to choose, taking into account a combination of factors such as the quality and brand of the drug, the doctor’s prescription or recommendations, the advice of a pharmacist, the patient’s habit of a specific name “that helps him,” and the price of the drug.
Selection and statistics
The ranking of these factors in terms of importance in our country strongly depends on geography. In Moscow and other large cities, brands are more often preferred, especially if they are recommended by pharmaceutical workers. The consumer’s attachment to a specific pharmacy or pharmacy chain, that is, a pharmacy brand, often implies his trust in the recommendations of the first capitalists and the products they offer. For buyers on a budget, no matter where they live, price is usually key.
One of the factors listed above still stands apart and claims to be the relative palm. We are talking about a doctor's prescription. Most patients are little aware of such professional matters as “original drug”, “generic”, and do not really understand what an “analogue” is. Even specialists sometimes have to remember which of the drugs of the same INN is the original, and which are its “copies” (especially when we are talking about names that have been on the market for more than a decade).
Buyers, as a rule, ask the pharmacy for the trade name that the doctor prescribed (recommended) and which is printed on the packaging in capital letters. The mass consumer usually does not focus on another name, which is printed in small print (INN). Thus, in many cases of outpatient treatment and especially in hospital practice, the choice between the original drug and the generic is made by the medical professional.
The realized preferences of consumers, medical workers, and healthcare organizers collectively form statistics. According to the marketing agency DSM Group, in value terms, the share of original drugs (drugs that are protected by a patent or were protected by a patent, that is, the first in the INN) in the Russian pharmaceutical market has not changed significantly over the past 3 years and is approximately 41%. In physical volume, 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 the DSM Group, the average cost of an original drug is approximately 500 rubles, while a generic drug is about 100 rubles. DSM Group predicts that there will be no significant redistribution of market shares in favor of generic drugs this year or next. A wave of changes is possible after 2014, when many original drugs will come out of patent protection.
Brand generics
Various trends are taking place in the global generics sector. Many preparations of generic drugs, of course, cannot be considered fully (therapeutically, pharmacologically) equivalent to their originals. But there are many opposite examples. The quality of the product of the leaders in the generic sector is high enough for the name of these companies to be perceived as a brand.
In addition, in an effort to provide additional sustainability to their business, some innovative companies are diversifying their activities by creating and developing a generic line. A case in point is Sandoz, the generics division of the Novartis group of companies. That is, the market for drugs based on generic drugs is heterogeneous, and from it a segment of “branded” generics can be distinguished, provided with the trademark and quality of technology from leading manufacturers. It follows 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 “unbranded.”
If this process takes on a “dumping” character, then the knowledge-intensive pharmaceutical industry, unlike many other areas of the economy, suffers rather than benefits from such trends. Every unit of profit lost by those who invest it in the research base, new developments, improving the production of original drugs and high-quality generics results in a slowdown in the pace of development of the innovative and technological potential of pharmaceutical science and industry. But it is hardly possible to limit these trends or introduce lower price thresholds.
Balance and perspective
It is not only innovative companies that are diversifying their activities. The policies of some leaders in the generics sector demonstrate 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 at 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 decreases from year to year. That is why Akrikhin is focusing its efforts on creating so-called “generic plus” products, that is, generics with added value (generics with signs of originality). At the same time, 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 future in relying on innovation, production of know-how, and products 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 product range, free from the influence of external factors and the economic situation. Other priority measures, according to Alexey Kovalev, are monitoring the validity of patents for original drugs and the production of branded generics. Compared to unbranded ones, their life cycle is longer and their price is higher. It remains stable for a long time and even grows. Among the measures contributing to the successful promotion of branded generics are: Alexey Kovalev denotes increased consumer awareness of this class of medicinal products.
However, not all manufacturers consider it possible and advisable to develop both directions. As Yuri Mochalin, director of corporate relations and government affairs at AstraZeneca, notes, there are industry participants who decide not to diversify their activities, and AstraZeneca is one of them. It looks quite attractive to have your own generics division, which would allow you to use new opportunities. However, AstraZeneca remains committed 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 don’t expect any deviations in our global strategy,” concludes Yuri Mochalin.
As the above data from the marketing agency DSM Group shows, the ratio of market shares of originals and generics has been quite stable in recent years. Time will tell whether Russia's recent accession to the WTO can influence this peculiar balance. There are currently insufficient grounds for a positive answer to this question. The ratio of original drugs to generics may be affected by the introduction of a drug insurance system. This is a separate big question, depending on which model of this social security mechanism will be taken as a basis in our country.
The generics market is already larger than the market for original drugs. And this trend will only increase.
The division of medicines into original and generic ones appeared in 1994, when the World Trade Organization adopted a package of documents regulating trade aspects of intellectual property rights. At the same time, the standard term of patent protection was established - 20 years. During this time, the manufacturer of a new drug is protected from the emergence of competitors, which makes it possible to “recoup” the funds invested in development and clinical trials and make good money.
Passed half
According to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), originator drugs accounted for just over a third of all drug spending worldwide in 2013. Over time, this share will decrease: with the expiration of patent protection for many expensive drugs and the entry of generics into the market, the segment of original drugs continued to decline. Thus, the growth of markets in developing countries is almost entirely due to the growth in the production of generic drugs. According to IFPMA forecasts,
By 2018, global revenues from the sale of generic drugs will reach $666-668 billion per year. Considering that the total global drug market could reach $1.31 trillion, generics already account for more than half of the overall market. In some regions, this figure is much higher - in South America (61% of all spending on medicines) and Asian countries (59%). The shift in drug consumption towards generics has long been a global trend.
“The price of entry to the market for pharmaceutical analogues has fallen due to intense competition. If not long ago the first generic drug that came out was something special and cost 20-30% cheaper than the original drug, today the very first analogue can be half the price of the original,” Nikolai, General Director of IMS Health Russia and CIS, told RBC+ Demidov. Therefore, for chemically synthesized drugs, which include most drugs in the low and medium price segments, we can talk about increasing accessibility for patients starting from the release of the first generic, the expert believes. It is known that within a year after the release of the first generic, the market is redistributed in its favor.
Biosimilars are winning back markets
A completely different story with analogues of biotechnological drugs. As Nikolai Demidov puts it, “strangers don’t come here.” The production of such drugs requires special high-tech conditions and significant investments already at the initial stages. Typically, in developing countries, after an expensive original drug loses patent protection, the local market for this item is monopolized by a locally sourced generic. Moreover, it is no more than 15% cheaper than the original medicine. Almost complete displacement of the original occurs within two to three years after the appearance of the generic product. “The exceptions are those medicines for which leading doctors of the relevant profile, for example, oncologists or rheumatologists, stand up strongly. We have seen angry speeches by specialists against generics more than once in recent years in Russia, explains Nikolai Demidov. “They prove that the original drug is a better cure or is indispensable for certain groups of patients, and the government has to continue to purchase the original even after the availability of a biosimilar.” Often this is not a completely objective assessment of the quality of a new, more affordable drug, the expert is sure, dictated by the marketing goals of the same Big Pharma, for which this is a way to keep a more expensive drug in government procurement for some time after the patent is completed.
According to this scenario, markets for biotechnological drugs are developing in China, Brazil, and India. An example of how original drugs are “washed out” of competitive procurement after the arrival of a generic can be found much closer: after domestic analogues of the expensive bortezomib produced by the F-Sintez company entered the market in 2014 (it replaced the original drug Jonson & Jonson), and rituximab produced by Biocad (replacing the Roche drug), the share of Russian drugs in government procurement under the drug benefit program increased from 4 to 69% (from 1.1 billion to 9 billion rubles). Domestic manufacturers of biological products have especially good prospects for those non-proprietary international names for which there were no local analogues before.
The situation is the same in the European market, Evaluate analysts note in their new study on the displacement of original biological products by biosimilars. This process will be accelerated in the coming years by the patent completion of blockbusters such as Humira (reduces the symptoms of rheumatoid arthritis) and Lantus (controls blood sugar) with total annual sales of $23 billion. These will be followed in 2018 by the anticancer drug Rituxan and Remicade ($18 billion) - rheumatoid arthritis, Crohn's disease, and in 2019 - Avastin (brain tumor) and Herceptin (breast cancer) with a total share of $23.3 billion. This will provide an opportunity to bring biosimilars to the market and will lead to a sharp loss of market share the most expensive drugs. It is worth noting that original drugs never disappear completely, since there are always patients who can afford them or for whom, due to their individual characteristics, analogues are not suitable (according to expert estimates, there are no more than 10% of these). The biosimilar market has existed in the world relatively recently: in Europe - since 2006 (19 drugs), in Japan - since 2009 (four drugs), in the USA only one biosimilar, Zarxio, produced by the Sandoz Corporation, is approved for use as an analogue.
Branded and unbranded
The Israeli company Teva has remained the undisputed leader in the global generics market for many years. On the Russian market, the Israeli giant was the first to begin promoting so-called unbranded generics. These drugs, which do not have their own trade name and are called either only by the active substance (INN - international nonproprietary name) or by the INN with an extension in the form of the company name, are just appearing on the Russian market.
This is a cheaper option than branded generics, but with the same quality guarantee. The very name of the company’s brand allows the patient to get his bearings and understand which manufacturer he trusts. By and large, it “lightens” the cost unbranded promotion is precisely the absence of a special brand name that needs to be “promoted”. Thus, promotion costs are reduced, which has a positive effect on the price. Unbranded generics allow the patient to approach financing their health more carefully and with perspective. In Russia, where there is no drug insurance system and the patient is forced to rely on his own financial capabilities, unbranded analogues have a great future, experts who monitor the market are confident in the context of declining real incomes of the population. Today, only one domestic manufacturer is represented in this segment - Akrikhin, part of the Polpharma group of companies; the company specializes, in particular, in the production of drugs for tuberculosis and other socially significant diseases.
“So far, only Pharmstandard is among the top 10 suppliers of medicines to the Russian market, but the situation will soon change, competition will intensify and become different in essence: instead of international players competing with each other, the time will come for competition with the growing domestic pharmaceutical industry,” - predicts Senior Vice President, General Director of Teva in Russia and the CIS Anna Yarvits.
It's about trust
The opinion that a copy is always worse than the original has always existed everywhere. But regulators in many countries have spent years making efforts to control quality and popularize the idea of taking generic drugs as the most rational consumption model, allowing those who previously could not even think of such a luxury to have access to modern treatments. The emergence of common standards for production and clinical testing in their modern form has largely alleviated the severity of the problem in the West. Inspections do not leave alone the production lines where original drugs are made, as well as biosimilars and generics. In our country, the inspectorate for the GMP (Good Manufacturing Practic) standard is only in the process of being created. So far, there are 31 certified inspectors working throughout the country, and pharmaceutical manufacturers are literally lining up to see them.
It is known that in the USA, a country where the consumption of generic drugs is still much lower than in the EU or Asian countries, the attitude of patients towards such drugs is becoming less wary. Data from a sociological study by Benenson Strategy Group show that 80% of American patients surveyed have nothing against high-quality analogues, since they are as safe and effective as the original drugs, but are also more affordable. The latter circumstance is important for patients who are forced to independently pay for long-term (often lifelong) medications.
,>
Loading...