At the XXIV National Congress “Man and Medicine”, session devoted to the achievements of domestic pharmaceutical industry in the field of biotechnological product development, the Head of the GEROPHARM Group Clinical Research Department presented the first-ever results of clinical trials of the domestic lispro insulin biosimilar.
GEROPHARM was the first company in Russia to organize and successfully conduct clamp studies for comparative evidence of insulin. In his report, Roman Dray drew attention to the fact that at that point the requirements of the Ministry of Health of the Russian Federation for research were practically the same as those of EMEA. The tests were carried out in accordance with the highest international standards.
In course of the studies, biosimilarity of the GEROPHARM preparation to the original insulin of ultrashort action Humalog® was proved (manufactured by “Lilly”). Comparable pharmacokinetic and pharmacodynamic profiles, as well as safety were established. The results of clinical trials are currently transmitted to the Ministry of Health. After the confirmation of immunogenicity absence, the company will be able to register the drug in the Russian Federation.
GEROPHARM is developing a line of insulin analogues that are currently at different stages of studying. Lispro insulin will be the first biosimilar of the original medicinal product in Russia and the first insulin biosimilar, which the company will bring to the market.