With the entry into the market of the world's first biosimilar eculizumab, Russia will have the opportunity to provide all Russian patients who need this medicine, as well as to end the monopoly of the American manufacturer that has existed since 2011.
The Russian analogue of the original drug eculizumab is officially registered and named "Elizarium". It differs from the original Soliris in its improved safety profile due to the use of modern cleaning methods.
A Russian company in the Vladimir region has been working on the creation of the drug for five years and received support from the Ministry of Industry and Trade of the Russian Federation under the Pharma-2020 state program.
Russia became the first country in the world that managed to establish a full production cycle of the eculizumab drug, including the production of a substance for it.
Eculizumab is used to treat rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
A year of treatment for a patient with PNH in Russia is 26-27 million rubles, for a patient with aHUS - 35-37 million rubles. In the world, the cost of the annual rate of use of eculizumab reaches 45 million rubles in terms of Russian currency.
The budget expenditures for the purchase of the original drug for Russian patients in 2018 amounted to 8.3 billion rubles, which exceeds one third of the costs for the treatment of all orphan diseases.
According to the head of the Ministry of Industry and Trade of the Russian Federation Denis Manturov, the drug created with the support of the state by the Russian pharmaceutical company Generium will cost a quarter less than the original, and the funds received from the project will be used for the further development of domestic biopharmaceuticals.
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