Interview of Dmitry Zemskov, executive director of Biokhimik JSC, to «Rossiyskaya Gazeta»

Biokhimik: 60 years on guard for the national safety of drug supply

Dmitry Nikolaevich, Biokhimik celebrated its anniversary in November. Congratulations to the plant staff on this round date! What achievements did the company celebrate its 60th anniversary?

Dmitry Zemskov: Of course, this is an important milestone in the development of the enterprise, which made the history of domestic pharmaceutical industry with the release of the first Soviet penicillin.

Our company, which came to the plant in 2015, has made the preservation of traditions a priority in its development, laying an innovative method as the basis. We set a course for the creation and production of Russian antibiotics, both original and equivalents of foreign ones. The task is not easy, requiring an integrated approach, large financial, intellectual and labor resources.

For four years we have managed to revive the enterprise, which for some time lost its former glory. We erected new workshops, equipped them with the most modern equipment, modernized production, and invited qualified specialists to the plant.

Today the portfolio of the enterprise has been updated by 60%. There are 100 modern and highly profitable drugs of various pharmaceutical groups at different stages of development and production, most of them are antibiotics. In 2019, more than 20 newest medicines, including those previously not produced in Russia, received marketing authorization certificates. In 2020, we plan to obtain approvals for another 40 products.

Another achievement for the anniversary date was a building with a new workshop for the production of active pharmaceutical ingredients, finished sterile preparations in liquid form and lyophilisates. Now a popular broad-spectrum antibiotic in the form of a lyophilisate is produced here. Let me emphasize that our plant is the only manufacturer of this product in the country. In the near future, on the basis of new sites, it is planned to launch the production of at least 11 drug products and three types of substances. Some of the drugs have already been approved by the Russian Ministry of Health. In the future, we will have one of the largest portfolios of modern drugs in various dosage forms.

Another pride of the plant is a hardware and software system for product serialization developed by the plant's specialists. Starting from January 2020, a mandatory drug labeling system will start in the Russian Federation. We have independently created a system that issues an individual passport for each drug: QR code contains information about manufacturer of the product, what API was used, when the product was released, when it was delivered to the warehouse, and when it was put into trade. Let me place emphasis: the software for this digital system is Russian. The development makes it possible to trace medicines from the manufacturer to the final consumer, which protects consumers from counterfeit products, and makes it possible to verify the authenticity of the produced drug. Any buyer will be able to read all product information using mobile phone.

Pharmaceutical safety has been and remains one of our priorities.

When Biokhimik launched the production of the first domestic antibiotics of a new generation a year and a half ago, it was a real breakthrough. Did you manage to solve the task of import substitution of certain drugs that previously were imported?

Dmitry Zemskov: After the crisis of the 1990s, which hit painfully the domestic pharmaceutical industry, Russian drug manufacturers lost their positions. Until now, Russia buys substances for most antibacterial drugs from China, India, South Korea, Europe and the United States. Realizing the importance of the task set by the country's leadership to ensure drug supply safety, the Biokhimik plant was the first in Russia to start producing strategic drugs using APIs developed by the company's specialists rather than imported raw materials.

Today we have mastered a full cycle commercial production of the reserve antibiotic vancomycin, which is used when other medicines fail to help. By 2021, our scientists and technologists will prepare for the launch of several more modern substances of glycopeptide antibiotics. Meanwhile, the technology of synthesis of antibacterial agents of the latest generations is being tuned: oxazolidinones, lipopeptides, cephalosporins.

New projects implemented by the company have attracted interest abroad. Tell us about the prospects for international cooperation of Biokhimik.

Dmitry Zemskov: Today Biokhimik is not only one of the leading players in the domestic pharmaceutical market, but also the major exporter of pharmaceuticals to the CIS countries and globally.

In 2018, we opened a sales office in Vietnam, and this year we obtained approvals for three antibacterial drugs there. Deliveries to this country will begin in 2020.

Now the plant is going through a rather lengthy audit procedure with Latin America – there are preliminary agreements with Mexico and Chile. Southeast Asia is undoubtedly among the promising areas. It is planned to supply there about 20 medicines, including antibiotics, drugs for cardiotherapy and neurology.

We pay special attention to these issues, because the development of the plant will largely depend on the competitiveness of our products in the global market.

Today in the Russian pharmaceutical industry it is necessary to restore not only production, but also human resources, scientific base. To solve these problems, Biokhimik has established cooperation with Ogarev Mordovia State University. Simultaneously with the launch of a new line for production of antibiotics, the Department of Chemistry and Technology of Physiologically Active Substances was opened at the plant. In summer, the first graduates have already been employed by the plant. How do you rate their level? Has the experiment justified itself?

Dmitry Zemskov: Training of personnel for a new production is very important, and we are successfully coping with it. Students who came to the plant after completing their training under the professional retraining program at the department opened by Biokhimik and the Mordovia State University smoothly joined our friendly team. They work as technologists, chemists, chromatographic engineers. We pin great hopes on them in the field of synthesis of new domestic antibiotics. For this, Biokhimik has created all the conditions in accordance with current international standards. About 40 more young men and women continue their studies under the university's bachelor program, and the payment for study of 20 of them are paid by the company.

By the way, this year, within the framework of the national project «Science», with the active participation of Biokhimik, the newest educational and scientific laboratory of chemical and pharmaceutical technologies was opened at the Institute of Physics and Chemistry of the Mordovian State University. Our plant financed the purchase of the most modern equipment for this laboratory. Thanks to this, students can now reproduce and thoroughly investigate almost all stages of the production of a drug – from the synthesis of active ingredient to the production of finished product. We are interested in highly qualified employees, so work in this direction will be actively continued.

Today our plant is rightfully ranked among the leaders in the Russian pharmaceutical market, and we do not intend to stop there. The company is developing steadily and looks confidently into the future.