Experts predict more novel biotech drug launches in Russia’s market

More than half (67%) of the drugs authorized in 2024 for the public segment are Russia-made. More and more domestic pharmaceutical producers are interested in long-term innovative projects. However, the cost of innovations and raw material restrictions remain a barrier for many, as discussed by experts at the 32nd Semashko Russian Pharmaceutical Forum.

New drug launches for the public segment last year promoted growth for Russian pharmaceutical companies as Russian drugs accounted for a 67% market share, with 37% still occupied by international medicines, says Anastasia Kruglova, General Manager at IQVIA.

Participants of the discussion held by pharmaceutical market leaders noted that biotech drugs are of greater interest to Russian market players today; however, launching such complex products costs companies hundreds of millions and sometimes billions of rubles. Funding may come from various sources, such as corporate optimization programs, IPO, etc.

Petrovax Pharm has developed its own approach.

"We invest all profits we make from retail sales in biotech drugs that help save people’s lives,"

emphasized Mikhail Tsyferov, President of Petrovax Pharm. "One of the striking examples is the debut plant fully localized in Russia, starting with the cell line substance, and set up to produce the orphan drug Fabagal used to treat Fabry disease. We were also the first in the market to register a denosumab biosimilar against osteoporosis."

Besides, cooperation with eastern companies can lower the cost of innovations. For example, in 2024, Petrovax Pharm partnered with a China’s major pharmaceutical producer to commercialize camrelizumab, an anticancer drug with unique indications.

The expert has highlighted that the Russian pharmaceutical industry makes original products in no part inferior than those of Western innovators, who often do not develop innovative molecules themselves, but buy their blockbusters from smaller biotech companies. Mr. Tsyferov predicts even more new launches in the biotech market in the coming years.

In addition to the cost of innovation, companies face other barriers on the path to import substitution, these including the search for local manufacturers of substances and auxiliary elements, in particular, packaging materials, delivery means, etc., experts believe.

Moreover, the introduction of innovative drugs to the Russian market and import substitution are still associated with a number of difficulties, despite the "national regime" applied to drug procurement.

"Russian pharmaceutical companies still need to solve production and sales volume issues, which they are unable to resolve through exports, as international manufacturers can,"

noted Kirill Danishevsky, Vice President for Communications, Petrovax Pharm. "We have launched several expensive drugs for orphan diseases, but not that many patients need those. We also had problems with organizing supplies simply working under Federal Law No. 44 since medical boards routinely prescribed expensive foreign-made drugs for patients."

Experts believe that it is essential to develop a better regulatory framework without infringing, however, on doctors’ rights and responsibilities and to include domestic drugs in clinical guidelines as the first-line therapy options, provided that they are of high quality and the outputs are sufficient to meet patient needs.

Despite all the obstacles, domestic pharmaceutical companies are striving to increase the share of locally produced drugs as this meets the government’s objectives to ensure drug safety and also drives exports. The participants believe that investment in complex innovative products is essential for promoting the export potential of the Russian pharmaceutical industry.

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