Clinical and economic aspects of the first biosimilar eculizumab use in patients with rare diseases

In March 2019, Elizaria® (JSC «GENERIUM»), the first biosimilar of eculizumab, was registered in Russia. This is the world's first experience in the release of a full-cycle biosimilar of eculizumab, including the production of a substance. Comparative non-clinical and clinical studies demonstrated the absence of toxicity, good tolerance, and comparability with the original medicinal product. Besides Russia, Elizaria® is currently registered in Belarus and Kazakhstan, and marketing activities are carried out in 14 countries. In 2019, Elizaria® already accounted for more than 75% of government purchases to provide patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The total expenses for these two rare diseases in 2020 amounted to about 8.9 billion rubles, while the introduction of a Russian biosimilar, the registered cost of which is 25% less compared to the reference medicinal product, in 2020 saved about 2.6 billion rubles and helped increase the number of patients receiving the therapy.