“We are considering two main aspects of drug safety: drugs must be available to patients both in terms of range and price, and we are talking about original drugs and generics,” said Deputy Minister of Health of the Russian Federation Sergei Glagolev at a session on drug safety.
At the federal level, decisions have been made to reduce the risk of defects, including accelerated registration of new drugs, digital indexing – these rules have been extended until 2026, the deputy minister noted.
“Under external pressure, we are simply obliged to ensure independent production of medicines. If one injection of a drug costs 130 million rubles, it means that we need to establish its own production,” stressed Alexander Petrov, a member of the State Duma Committee on Health Protection.
Indeed, last year Russia registered its own development of BIOCAD – an analogue of the imported Zolgensma, one of the most expensive drugs in the world intended for the treatment of SMA.
Innovative medicines for the treatment of orphan diseases and oncology drugs are the most expensive, so their import substitution is an important trend. Another example is the project of the Petrovax company in partnership with the NICEM named after. N.F. Gamaleya on the deep localization of the drug “Fabagal” (agalsidase beta) for the treatment of Fabry disease.
“For the first time in Russia, we have transferred technology for the production of an orphan drug from a cell line – in just two years. The drug has already been registered in our country. And its price is almost two times lower,” said Vladislava Torshina, managing director for budget sales of the development company .
V. Torshin and V. Vargin at the session “Medicine Safety”. Photo: Anatoly Strebelev/Roscongress
It is possible to ensure technological sovereignty if the state supports domestic developments and creates conditions when it is also interesting for private businesses to invest in innovation, noted Deputy Minister of Industry and Trade Ekaterina Priezzheva. And Sergei Glagolev emphasized that we need “transparent tools for predicting the relevance of a particular drug, its inclusion in clinical recommendations and the list of vital and essential drugs.” These mechanisms ensure stable demand for the drug.
At the same time, the discussion participants noted that some factors reduce the availability of analogues for patients. Thus, many auctions for the purchase of drugs for the treatment of Fabry disease are announced under the trade names of expensive foreign drugs on the recommendation of medical commissions, although the Russian analogue has confirmed its quality and safety.
Similar difficulties are typical for our market: for example, the experience of introducing Russian high-quality genetically engineered insulins was also difficult and required effort and time. Meanwhile, the opinion that an imported drug is “always” better than a Russian one has long been outdated. Large Russian companies have switched to international production standards – the same ones by which the world’s big pharma operates. “The requirement to produce drugs according to international GMP standards, introduced in Russia, is a guarantee of their effectiveness and safety,” emphasized Ekaterina Priezzheva.
According to Glagolev, it is important to monitor the validity of the registration of drugs according to the decision of the medical commission. Representatives of the pharmaceutical industry, in turn, proposed to “raise” the purchase of drugs for Fabry disease from the regional to the federal level – this will ensure budget savings and equal access to therapy for all patients.
Another barrier slowing down the introduction of innovations into clinical practice is the timing of inclusion of new drugs in clinical guidelines and the list of vital and essential drugs. Now this process takes more than 1-2 years. Until these procedures are completed, patient access is extremely limited.
Cooperation with the BRICS countries opens up broad prospects for innovative development; many projects were discussed at the recent forum in Kazan, noted Alexander Petrov.
“The pharmaceutical industry in China has grown at a tremendous pace. For example, in 2021, the volume of venture investments in Chinese startups amounted to a billion dollars. Chinese innovations are becoming more attractive to big pharma. Already 6 original drugs have been approved by the American regulator, 5 of them in the field of oncology. We We follow the trends and have already licensed the Chinese original anti-cancer drug camrelizumab, including a unique orphan indication – nasopharyngeal carcinoma,” said Andrey Boldyrev, managing director for development of the biotechnological portfolio of Petrovax, at a session on innovative development.
In Russia, this type of carcinoma is treated only with chemotherapy, and the mortality rate remains high. The original immuno-oncology drug, the registration of which should be completed by the end of the year, will give doctors and patients new treatment options. In the future, the company plans to localize the full production cycle of camrelizumab in Russia.
A. Boldyrev and A. Kamalov at the session “Innovation in Action”. Photo: Igor Russak/Roscongress
Source: rg.ru
