GEROPHARM is the first in Russia to conduct clamp studies of insulin biosimilars

| By | Biosimilars, Geropharm, R&D

GEROPHARM research center located in Strelna Special Economic Zone is engaged in a full cycle of advanced insulin drugs development.

The experts of the company are working on creating a line of insulin biosimilars with different duration of action. The R&D activities are carried out in accordance with EAEU requirements and based on international best practices, including EMA and FDA guidelines.

The efforts of the research center are aimed at developing the technologies that have high social value and strengthen the national drug provision security.

GEROPHARM was the first company in Russia to conduct clamp studies of insulin biosimilars. The clinical trials of two drugs have been successfully completed, and the results were submitted to the Ministry of Health. After the registration, they will be manufactured at the new GEROPHARM plant in the city of Pushkin.

The insulin production line (for genetically engineered insulins and insulin biosimilars) will be capable to manufacture 1000 kg of the substance a year, which will allow to fully meet the needs of Russia in insulin (about 800 kg a year) and increase the export capacity of the company.