According to data from the state registry, Russian pharmaceutical company Geropharm has received Ministry of Health approval to conduct Phase I clinical trials of the combination insulin degludec + insulin aspart (development code GP40231). This is a biosimilar of the original drug Ryzodeg from the Danish pharmaceutical giant Novo Nordisk, used for type 1 and type 2 diabetes. The drug’s active substance is included in the List of Vital and Essential Drugs and accounts for a significant share of the tender market.
The trials will be conducted at the Dedov National Medical Research Center and Clinical Hospital No. 3 in the Yaroslavl region. The clinical trial approval will be valid until the end of 2027.
As reported by the analytical company Headway, over the 10 months of 2025, government institutions purchased the original Ryzodeg for a total of 1.19 billion rubles. This accounts for 1.82% of the entire market for diabetes medications. The original drug has been registered in Russia since 2013; its manufacturing is carried out in Denmark, while packaging and quality control release are performed at Novo Nordisk’s plant in Kaluga.
In 2025, the Russian Ministry of Health issued an approval for Phase III clinical trials of GP40131 (insulin degludec), developed by Geropharm. The study is designed to compare the immunogenicity of the Russian biosimilar with the original drug Tresiba from Novo Nordisk.
Insulin degludec is an ultra-long-acting basal insulin analog administered once daily. It is a recombinant human insulin with a fatty acid residue attached to lysine. Immunogenicity studies are necessary to assess the safety of the drug’s use.
