17 October 2013

Biopharmaceuticals in Russia

"The Russian market is moving towards the creation of generics"

Nadezhda Markina, <url>About the situation in the field of biotechnological and pharmaceutical developments in Russia "Newspaper.

Ru" was told by Doctor of Chemical Sciences, President of the Society of Biochemists and Molecular Biologists Alexander Gabibov.

– What tools do the Russian authorities use to help develop domestic medicine and biotechnologies?

 – This year, the Ministry of Industry and Trade of the Russian Federation has established a scientific and technical council, which considers projects submitted by companies, scientific institutes, universities within the framework of the implementation of the Pharma 2020 program. This is a state program aimed at import substitution of foreign drugs with domestic ones and the development of the pharmaceutical industry in Russia. Employees of the Ministry select projects and submit them to the members of the Council. There are projects on clinical and preclinical trials of new drugs, projects on "import substitution" and there is a system for submitting applications for "technological transfers" of new medicines and technologies. The system created over the past two years seems to be a well-established mechanism and, in my opinion, can significantly improve the situation on the domestic pharmaceutical market.

– As for biotechnologies, are there modern innovative developments in Russia that are used in the domestic and foreign markets?

– Frankly speaking, there are not many of them. This is due to the practical "extinction" of industry science and the relative weakness of the R&D departments of domestic companies. The sector related to the development of monoclonal antibodies, delivery vehicles, vaccines and the creation of long-acting drugs has started to develop well.

– Can you give specific examples?

– In Russia, analogues of antibodies are being created that are available on the Western market. For example, rituximab used for leukemia. It is a monoclonal antibody to the CD 20 antigen on the surface of B lymphocytes. Remicade, also a monoclonal antibody, is used for rheumatoid arthritis. These antibodies were created in the West, and work is underway in Russia to create high-quality generics.

– Is there any medical equipment of domestic production in Russia? As you know, there are developments. So, there was a program "Fundamental Science – medicine", within which domestic physicists developed quite a lot of medical devices. Has any of this reached the market?

 – I am less familiar with medical equipment than with the pharmaceutical sector. The Ministry of Industry and Trade has a separate NTS dedicated to this problem. At the same time, I will say that we have good developments on the radio diagnostic complex – devices for anesthesia. Unfortunately, in most cases, Russia is heavily dependent on imports.

– What should be the right balance between supporting domestic developments and purchasing the latest foreign developments? How does the Federal Target Program answer this question?

– I have already said that there is support for so-called technology transfers, where we are talking about the transfer of technologies from abroad to drugs of varying degrees of readiness. And there is support for preclinical and clinical trials of domestic drugs brought to this stage. I think the latter should prevail significantly. For example, a 1:3 ratio looks reasonable. But to do this, it is necessary to significantly raise the level of biomedical research. The works of the Research Institute of Pharmacology of the Russian Academy of Medical Sciences and the Gamalei Institute look good in this sense.

– Could you name specific promising developments of these institutions?

– Very interesting antibacterial and antiviral drugs are being developed at the Gamalei Institute. And in the Research Institute of Pharmacology, low–molecular drugs are neurotropic, such as mexidol, afobazole, they certainly deserve attention.

– And the peptide ones?

– If you turn to Western pharmacology, they are not very good. In the West, what is the approach: they look for a target receptor, make an antibody on it and turn it off. So far, such a chain is not working well for us.

– As president of the Society of Biochemists and Molecular Biologists, can you give examples of successful applied research in the field of Life sciences, which would be carried out thanks to the support of the Ministry of Industry and Trade of the Russian Federation?

 – I think that a number of drugs from the above institutes, in particular, neuro-oriented and antiviral, look quite serious. I would also mention developments in the field of prolonged medicines based on recombinant proteins. In general, there are quite a few Russian innovative developments. Now the Russian market is moving towards the creation of generics. And maybe this is the right way to grow the pharmaceutical industry, because we need to create a base.

– In your opinion, what are the most interesting and promising pharmaceutical developments that have recently appeared in the world and in Russia?

– In the world, this is, of course, work in the field of anti-cancer therapy based on inhibitors of receptor protein kinases, a system of anti-cytokine antibodies and antibodies to B cells (Rituximab). In Russia, I would delay with the name of the leader. The region is just getting back on its feet.

– Does the Ministry of Industry and Trade of the Russian Federation attract domestic business for the production of medical and biotechnological equipment? Is it possible to do this business in Russia?

 – Of course, it attracts. It is necessary to expand this business by creating more goods for the disabled that require a special import substitution program. Russia can produce these products by itself. Russia can successfully use its leading positions in the industry of isotopes, contrast agents based on them, detectors.

Portal "Eternal youth" http://vechnayamolodost.ru17.10.2013

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