Ustekinumab is a human immunoglobulin IgG1k, a monoclonal antibody targeting interleukins IL-12 and IL-23, produced using recombinant DNA technology.
The drug has several indications for use: plaque psoriasis and psoriatic arthritis in children and adults2. In Russia, patients receive it through the state-funded drug supply program.
Daniil Talyansky, CEO of GENIUM:
"GENERIUM continues to implement its program to improve access to complex, life-saving drugs for patients in Russia and abroad. The biosimilar of ustekinumab has passed Phase I and Phase III clinical trials, with the latter conducted across 33 medical centers and involving 422 patients. In the very near future, the drug will become available to a wide range of patients."
According to the clinical guidelines of the Ministry of Health of the Russian Federation2, psoriasis is one of the most common skin diseases, affecting 1–2% of the global population. In 2021, the prevalence of psoriasis (total known cases) in Russia was 243.7 per 100,000 people, while the incidence rate (newly diagnosed cases per year) was 59.3 per 100,000 people.
GENERIUM’s drug is the first registered biosimilar of ustekinumab in the Russian Federation. The drug is available as a solution for subcutaneous injection.
The development, preclinical, and clinical studies of the drug took GENERIUM scientists nearly 8 years to complete.
This is the second biotechnological product in the field of rheumatology developed by GENERIUM. The company’s drug with the INN tocilizumab, for the treatment of rheumatoid arthritis (including systemic juvenile idiopathic arthritis), severe COVID-19 conditions, and life-threatening cytokine release syndrome, was registered in September 2024.
"The registration of the Russian biosimilar will expand treatment options for autoimmune diseases and improve patient access to therapy," the company's representatives noted.
1 LP-№(008781)-(RG-RU)
2 EAEU Register of Essential Medicines: https://lk.regmed.ru/Register/EAEU_SmPC