03 June 2010

Russian pharmaceutical industry: place bets!

Domestic science is hopeless
Natalia Bykova, STRF.ruWhat should the Russian pharmaceutical industry rely on: imported technologies or domestic original innovative drugs?

Vladimir Kolyshkin, Vice President for Production of the Bioprocess Group of Companies, believes that the way of borrowing is more promising for our pharma, as well as for the automotive industry.

In the development strategy of Pharma 2020, one of the main tasks is to increase the share of domestic products in the total volume of consumption in the domestic market to 50 percent in value terms by 2020. According to your estimates, is it realistic to complete this task?– Yes and no.

The situation is different for different types of products. As for antibiotics, if a full production cycle is created in Russia, this goal is difficult to achieve. If we talk about biopharm, it is likely that the task will be completed. If we are talking about vaccines, then today they are produced in greater volume in the Russian Federation. It is difficult to assess the situation with chemical and pharmaceutical preparations, rather, the development of generics is more promising here, provided that substances produced in the Russian Federation will be competitive with Indian and Chinese ones.

Due to what can an increase in the market share of domestic producers be achieved?– Due to the introduction of technologies from abroad and from the state regulatory authorities, economic incentives for manufacturers to introduce new technologies.

I don't think it's worth pinning great hopes on the domestic fundamental science. Almost all the scientists who were "focused" on the result went abroad and work there, in bigfarm. Those who remained are "imprisoned", as a rule, for scientific interest. They are all very good, intelligent people, but they conduct experiments, the purpose of which is the experiments themselves. They're just wondering what will come of it. And people who produce medicines are primarily interested in what can be introduced into production.

But a job based on interest also does not exclude getting a decent result.…– The criterion of truth is practice, and in recent years there has been little "heard" about the introduction of original innovative drugs into the production of domestic products, except for loud statements.

Scientists usually say that the whole point is the unwillingness of the domestic pharmaceutical industry to accept their developments.– Thank God, there is a biopharmaceutical industry in the country.

There are companies that produce completely domestic innovative drugs, but this is, for the most part, an exception to the rule. Strictly speaking, then
according to the efficiency of the processes, the Russian developments proposed for implementation are obviously less advantageous than those with which foreign scientists are currently working.

Therefore, in this situation, in my opinion, the way of borrowing is the most promising. In general, the experience of the automotive industry is very suitable for an example. Foreign cars that are produced here in Russia travel around the country. Of course, our car industry is able to present one–piece copies, for example, KAMAZ, which regularly wins the Paris- Dakar rally, but such cars are not produced en masse ...Russia has always been famous for being able to develop single high-quality products "to order". The release technology implies the reproducibility of the process by a trained, more or less literate person, and not by some supersmith who masterfully closes the matchbox with an industrial hammer.

If we talk not about the developers, but directly about the pharmaceutical industry, its positions in the domestic Russian market, it often becomes obvious that the consumer does not fully trust the drugs of domestic production. What do you think is the reason for this attitude?– Mainly in the traditions of self–medication in our country, aggressive advertising of foreign big pharma.

Naturally, this primarily applies to drugs that are freely sold through the pharmacy network. As for the hospital sector, a doctor makes a decision there, and it is not a fact that it will be in favor of an imported drug. Although it is worth admitting that in the last decade we have significantly lagged behind with the introduction of modern medicines.

For example, corticosteroid hormonal drugs with pronounced side effects that are far from beneficial to health were previously used to treat rheumatoid arthritis. Some time ago, a drug based on therapeutic monoclonal antibodies was created abroad, with the help of which a huge number of people are saved without significant side effects. In the Russian Federation, this drug is not produced today.

In my opinion, the National Calendar of Preventive Vaccinations should also be expanded and updated through the introduction of new, including combined, vaccines. In our country, 10 infections fall under mandatory vaccination. In developed countries, there are significantly more of them. For example, the problem of vaccination against pneumococcal infection in Russia has not been solved.

Have you found out what to hide… Technological equipment is gradually aging at enterprises producing vaccines. There are big problems with young cadres. After all, GMP is mainly in the heads, and not "in the hardware". A new factory was opened in which everything meets international requirements, the ribbon was cut, but then insufficiently trained personnel came there, and this is where compliance with GMP requirements ends.

In order to overcome all this, it is necessary to tighten the basic training of students who will come to work in the pharmaceutical industry, update the instrumental and technological base of enterprises and engage in educational work with the population.

What is the strategy of the company "Bioprocess" to expand the market share of interferon?– The structures of the Bioprocess company today produce genetically engineered interferon alpha-2b and human leukocyte interferon.

At the same time, the substance of the genetically engineered interferon alpha-2b provides about 80 percent of the market volume of Russian manufacturers of finished dosage forms. On the basis of this substance, a drug under the commercial name Altevir is also manufactured. Leukocyte interferon is not branded. "Bioprocess" covers about 30 percent of the needs of this segment of the Russian market. We are trying to increase its share by creating new dosage forms, including prolonged ones.

Generally speaking, there are a lot of plans. Naturally, we strive to expand the range of medicines, including through the production of new recombinant therapeutic proteins, therapeutic monoclonal antibodies. We are trying to provide a campaign related to the National Calendar of Preventive Vaccinations with combined highly effective vaccines.

Portal "Eternal youth" http://vechnayamolodost.ru03.06.2010

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