Import and analogues: what medicines are filled in Russian pharmacies?

The productivity of the Russian pharmaceutical industry increased by 15% by the end of the year. This assessment was given in a conversation with RBC Petersburg by Sergey Shulyak, CEO of the marketing company DSM Group. At the same time, the share of localized drugs in pharmacy sales remained virtually unchanged: in January-September 2022, according to DSM Group, it amounted to 64.9% (in packages); for the same period in 2021 - 65.1%. Due to what the St. Petersburg pharmaceutical industry grew and what the import substitution indicators say - in the material of RBC Petersburg.

What height

Almost all pharmaceutical companies surveyed by RBC Petersburg reported an increase in production or sales in 2022. For 11 months of 2022, Pharmasyntez-Nord produced 1.5 million units more than in the same period of 2021. The press service of the company associated this with the expansion of the range of products. “The increase in production volume is planned, the steady growth of oncological diseases in the world and in the Russian Federation, the improvement in the detection of oncological diseases causes an increase in the need for anticancer drugs,” the company said.

For 11 months of 2022, GEROPHARM increased its market share in the insulin market by 1.5 times in the segments of presence — from 43% to 61% in the segment of analogues and from 20% to 32% in the market of genetically engineered human insulins. The total production of GEROPHARM finished dosage forms of insulin increased by 55% over the three quarters of 2022 compared to the same period last year. “These results were made possible by leveling the risks of non-deliveries by promptly changing suppliers and restructuring supply chains, on the one hand, and on the other hand, increasing confidence in Russian drugs plays an important role,” the company’s press service said.

Georgy Pobelyansky, General DIRECTOR of the pharmaceutical company VERTEX, spoke about the increase in sales in 2022 by 11% in units and about 25% in monetary terms compared to 2021. RBC Petersburg was also informed about the increase in production from January to November 2022 compared to the same period last year in BIOCAD.

What's New

In addition to increasing the volume of production of previously registered drugs, pharmaceutical companies launched new products in 2022. According to the press service of GEROPHARM, the production of Molnupiravir-GEROPHARM was launched at the company's production site in St. Petersburg in June. It is an antiviral drug that is used to treat covid-19 . “For six months, the company’s employees worked on the molecule, developed and transferred the dosage form to the production site, conducted the first phase of clinical trials, launched the third phase and completed a number of other important tasks in order to obtain a registration certificate,” GEROPHARM shared.

BIOCAD registered pembrolizumab in early December. It is used to treat more than ten cancers, including melanoma, lung, kidney, endometrial, cervical, and HEAD and neck cancers. According to the press service of the company, clinical studies have proven the equivalence of pembrolizumab produced by Biocad and the original pembrolizumab produced by the American company Merck & Co. Inc. “The release to the Russian market of a domestic biosimilar developed by our company can provide 25% more patients with therapy without increasing the burden on the healthcare budget,” BIOCAD said.

Georgy Pobelyansky told RBC Petersburg that over the past year, the portfolio of the pharmaceutical company VERTEX was replenished with about 15 new drugs, taking into account different packaging and dosages, this is about 30 positions of drugs. “Among the new products is the company's sixth original combination drug, which has no analogues, is an over-the-counter medicinal varnish for the treatment of fungal nail infections. The portfolio also includes branded medicines and generics under international non-proprietary names for use in dermatology, cardiology, neurology, gastroenterology, etc., several positions of the drug from the list of vital and essential drugs with the active ingredient tranexamic acid for the prevention and treatment of bleeding,” says the head companies.

Dmitry Borisov, General Director of POLYSAN NTFF, said earlier that the company's main activity in import substitution is related to the production of substances. As for finished drugs, this year POLYSAN launched a new antihistamine drug on the market, previously all its analogues were imported.

Plans for the future

In the future, pharmaceutical companies in St. Petersburg are preparing to release dozens of new drugs. For example, the press service of BIOCAD RBC Petersburg reported that the company is conducting 37 clinical trials that are in different phases. “In 2022, we received more than ten permits from the Russian Ministry of HEALTH to conduct clinical trials. Currently, BIOCAD is conducting clinical trials of drugs for the treatment of socially significant diseases, including melanoma, non-small cell lung cancer, neuroblastoma, cervical cancer, axial spondyloarthritis, multiple sclerosis, and others,” the company said.

Currently, GEROPHARM is developing more than twenty projects, a number of which are designed to replace foreign drugs. Among them are drugs in the field of endocrinology, in particular, the company is developing four insulin drugs. PharmsynthezNord named the innovative leukemia drug PF-114, which is undergoing the third phase of clinical trials, as one of the company's promising drugs. VERTEX is developing several original combined drugs, some of the drugs have passed to the stage of clinical trials and registration. As Georgy Pobelyansky clarified, a significant part of the drugs in development are generics of original foreign drugs.

Import substitution is slow

While the share of Russian drugs in pharmacy sales remained virtually unchanged over the three quarters of 2022, it slightly increased in the structure of public procurement. According to DSM Group, the share of localized drugs in the state segment in January-September 2022 amounted to 83.6% (in packages). For the same period in 2021 - 82.2%. At the same time, the share of Russian drugs in rubles remained at the same level - 46.8%.

As Sergei Shulyak explains, in order for the market share of Russian pharmaceutical companies to increase more noticeably, they need to grow much faster than the market itself. “It may seem that a 1% increase means nothing. But it is also quite an important indicator. It means that in the context of continued supplies from abroad, Russian pharmaceuticals manage to outpace the growth of the market as a whole. Considering that the market at the end of the year, according to preliminary estimates, grew by 11-13%, Russian pharmaceuticals grew by about 15%,” Shulyak said. In his opinion, it is impossible for domestic pharmaceutical companies to increase the pace even more in the current conditions: they have encountered difficulties in the supply of imported substances and equipment. Another difficulty is that the Russian consumer is still committed to foreign drugs.

At the same time, Sergei Shulyak notes, the share of drugs produced in RUSSIA has been increasing for many years. This was facilitated by the localization of production by foreign companies, the construction of new factories in the country by Russian companies and other investors.

Thus, the growth in production in 2022 is a consequence of the long-term strategy of the pharmaceutical industry. “It is important to understand that pharma is a knowledge-intensive industry, and its growth should not be associated with the challenges of this particular year. Because the synthesis of innovative drugs takes time and resources. The pharmaceutical industry is deeply integrated and dependent on the chemistry used to make substances. Unfortunately, in order to fully produce all the medicines, Russia lacks substances and chemical components,” the expert notes.