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The first biosimilar of romiplostim has been registered in Russia

10/16/2023
The first biosimilar of the orphan drug romiplostim has been registered in Russia, which is used as a treatment for immune thrombocytopenia and is included in the List of Vital and Essential Drugs. The registration certificate for the drug "Stimplate" produced by the company "Generium" was issued by the Ministry of Health of Russia.
The first biosimilar of romiplostim has been registered in Russia фото

Immune thrombocytopenia is an autoimmune disease in which the human body produces antibodies that lead to increased platelet destruction and insufficient platelet formation. As a result, the blood clotting process is disrupted, which can manifest itself as spontaneous and post-traumatic bleeding. Romiplostim stimulates the formation of platelets and the cells that synthesize them, thereby normalizing blood clotting function.

Stimplate produced by Generium is indicated for treatment of primary immune thrombocytopenia in adult patients resistant to other types of treatment, for example, glucocorticosteroids, immunoglobulins, as well as for the treatment of chronic primary immune thrombocytopenia in children one year of age and older, resistant to other types of treatment.

“The Ministry of Industry and Trade of the Russian Federation has identified promising areas for the development of the pharmaceutical industry. Our focus is on biotechnology and full-cycle medicine production. In Russia there are many reliable manufacturers of such medicines, the latter being modern, in demand in Russia and abroad, and Generium is one of such manufacturers,” – emphasized Deputy Minister of Industry and Trade of the Russian Federation Ekaterina Priyezzheva.

An international multicenter study of the clinical effectiveness and safety of Stimplate was conducted in 30 research centers in Russia, Belarus and Kazakhstan, with 160 patients as participants.

“Providing orphan patients with modern effective medicines is what Generium works for.” Steamplate was another step on this path,” – said Daniil Talyansky, General Director of Generium.

It is worth noting that romiplostim is included in the List of Vital and Essential Drugs, therefore patients in need of therapy are provided with it at the expense of regional budgets.

On the company: Generium is a Russian innovative full-cycle biotechnological research and production company, a leader in the orphan segment of the Russian pharmaceutical market. The company has its own R&D park, capable of developing any medicine from molecule design to start of industrial production, including gene therapy and ATMP. Scientific research on individual medicines is carried out jointly with biotechnology companies and scientific institutes from around the world. The company's production site is organized in strict accordance with international GMP standards and can produce a unique range of drugs in its diversity.