Elizaria®
INN: Eculizumab
A humanized monoclonal antibody that binds to the human complement protein C5 and inhibits the activation of complement-mediated cytolysis.
Elizaria® inhibits the activation of the terminal complement complex in humans, restores the regulation of complement activity in the blood.
Elizaria® prevents intravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH), as well as excessive activation of the terminal complement complex in patients with atypical hemolytic uremic syndrome (aHUS).
Eculizumab treatment in patients leads to a significant decrease in hemolysis, frequency of thrombosis, dependence on blood transfusion in patients with paroxysmal nocturnal hemoglobinuria, and also significantly improves renal function in patients with atypical hemolytic uremic syndrome.
Indications for use:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
GENERIUM is the only company in the world that has developed and manufactured a biosimilar of Eculizumab.
- A case report of atypical hemolytic-uremic syndrome treatment with the first Russian eculizumab in adult patient. Authors: Lavrishcheva IV, Jakovenko AA, Kudlay DA 2020 yr.
- Phase III Clinical Trial of Elizaria® and Soliris® in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria: Results of Comparative Analysis of Eicacy, Safety, and Pharmacological Data. Authors: Aleksandr Kulagin Vadim Ptushkin, MD PhD Professor Elena Lukina, MD PhD Professor Elena Gapchenko, MD Oksana Markova, MD MSc Eugene Zuev, MD Dmitry Kudlay, MD PhD Professor 2020 yr.
- Clinical and Economic Aspects of the First Biosimilar Eculizumab use in Patients with Rare Diseases. Authors: Ivan S. Krysanov, Vera S. Krysanova, Viktoriya Yu. Ermakova 2022 yr.
- Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab. Authors: Alexander D. Kulagin, Vadim V. Ptushkin, Elena A. Lukina, Igor L. Davydkin, Alexander V. Korobkin, Vladimir S. Shamrai, Tatyana S. Konstantinova, Tatyana S. Kaporskaya, Tatyana A. Mitina, Tatyana I. Ksenzova, Evgeny V. Zuev, Oksana A. Markova, Elena V. Gapchenko, Dmitry A. Kudlay 2021 г.
