Post-genomic technologies of domestic production
"There is a common name for this phenomenon – postgenomic technologies"
Galina Papernaya, "Moscow News", 26.04.2012
Andrey Ivashchenko, Chairman of the Board of Directors of the Himrar Group of Companies, one of the authors of the Pharma 2020 pharmaceutical industry development concept, believes that Russian companies should at least win their market by taking advantage of the competitive advantage that the current domestic legislation gives them.
– How can we characterize biotechnologies, which we are used to hearing about, as the main factor in the development of medicine of the future?
– Speaking about biotechnologies, we narrow the boundaries of the phenomenon under consideration too much. It is necessary to talk about biological systems or life sciences, which generate a whole range of phenomena, including biotechnology.
In general, there is a common name for this phenomenon – postgenomic technologies. That is, when talking about biotechnological drugs, we are talking about drugs whose development has become possible thanks to the data obtained as a result of genome decoding. Decoding the genome of humans and other living beings has generated a lot of additional knowledge and has given an idea of the many previously unknown processes that occur in living cells. If earlier all understanding in this area ended at the level of individual organs, then after decoding the genome we were able to understand what is happening not only at the cellular level, but also at the level of individual molecules.
– What have these discoveries already given to practical medicine and will they give in the future, in your opinion?
– Biotechnological drugs have appeared – monoclonal antibodies. That is, these are not such small synthetic molecules and not even the first protein preparations, such as, say, interferons or insulins, but large proteins obtained as a result of biosynthesis in mammalian cells. Their great advantage is that they are harmless to the human body. Now dozens of such drugs worth billions of dollars are being sold in the world. Many of them will lose patent protection in the near future, and many biosimilars will appear, which should lead to a decrease in the price and increase the availability of these drugs at times.
The second example of the use of postgenomic technologies in medicine is the development of so–called biomarkers, that is, tests that allow even before the start of treatment to determine whether a particular drug is suitable for affecting the cells of a particular tumor. The first biotechnological drug to which such a test was released, and which quickly began to be sold bundled with it, was the famous breast cancer drug Herceptin, developed by the biotechnology company Genentech in 1998. Hundreds of such pairs of targeted drugs are currently in development, with test systems for them.
– What are the main differences between the production of biotechnological targeted drugs and conventional drugs?
– For clarity, I will give an example. Our state annually purchases bortezomib for the treatment of myeloma and lymphoma in the amount of more than $ 100 million. In order to produce such an amount of the drug, only 1 kilogram of the substance and several small well-equipped rooms are required. And to produce the popular drug arbidol, the market of which is estimated at about the same amount, you need several tons of substance and a whole plant.
– Some Russian and foreign pharmaceutical companies with production facilities and research units in Russia claim that they have already started producing monoclonal antibodies in our country. But there is no evidence that these drugs were on the market. Why?
– We are indeed already making such drugs, but it is not yet possible to bring them to the market. It is clear that there are those companies that took their place in the market first. Their representatives are working to convince regulators around the world (including Russian ones) that biosimilar drugs do not exist. That any biotechnological medicine should be recognized as fundamentally new and subjected to all clinical trials that are required for the first time drugs being put on the market. I know that there is a big debate going on in the Ministry of Health and Social Development on this topic, in which our Western partners – large pharmaceutical companies whose patents are expiring – are struggling to promote the idea of regulation "like in America or like in Europe." But in fact, the opposite trend is now noticeable in Europe and America: the easing of pressure to allow manufacturers of biosimilar drugs to enter the markets. After the crisis, they have to look for new ways to provide their citizens with affordable drugs. In order to reduce prices, competition is increasing in the West. As always, we are one step late, trying to copy their pre-crisis model. If we do adopt the toughest regulatory model for bringing biotechnological drugs to the market, then this industry will stall altogether.
– And with full clinical trials of new monoclonal antibodies, Russian biotechnology has no chance of surviving at all?
– It does, but it will be more expensive. In general, in order to prove in our time that one biotechnological drug has the same properties as another previously known on the market, it is not necessary to test it on thousands of people. Science is developing very quickly, and adequate preclinical models and many other methods have appeared that allow us to say how similar two biological molecules are or not. The whole world is now following the path of development of so-called translational medicine, which is designed to reduce the number of tests on patients and move all research to the laboratory as much as possible.
Moreover, we never say that the classic antibodies that entered the market almost 20 years ago can now be remade much better. After all, during this time, technology has changed incredibly. A new improved biosimilar can work much better than an antibody isolated in the distant past. This direction of upgrading biopharmaceutical products is called biobetter and is used in many countries. But, for example, American companies that once made original drugs themselves, and, of course, could have improved them several times on their own, it is not profitable to do this because of the same regulatory strictures in the United States. We must use the competitive advantage that our current situation gives us.
Portal "Eternal youth" http://vechnayamolodost.ru28.04.2012