Geropharm Advances Biosimilar Development with Phase I Trials for Novo Nordisk's Diabetes Combination Therapy
核心洞察
Russian pharmaceutical company Geropharm (搜索) has received Ministry of Health approval to conduct Phase I clinical trials of GP40231 (搜索), a biosimilar of Novo Nordisk's Ryzodeg combination insulin therapy for diabetes (搜索).
The original Ryzodeg drug represents a significant market presence, with Russian government institutions purchasing 1.19 billion rubles worth over 10 months in 2025, accounting for 1.82% of the diabetes (搜索) medication market.
Geropharm (搜索) is simultaneously advancing Phase III trials for GP40131, a biosimilar of Novo Nordisk's Tresiba insulin degludec, demonstrating the company's comprehensive approach to diabetes (搜索) biosimilar development.
Russian pharmaceutical company Geropharm (搜索) has received Ministry of Health approval to conduct Phase I clinical trials of GP40231 (搜索), a biosimilar version of Novo Nordisk's combination diabetes (搜索) therapy Ryzodeg. The development represents the first biosimilar attempt of the Danish pharmaceutical giant's insulin degludec + insulin aspart combination, which is used for treating both type 1 and type 2 diabetes (搜索).
Clinical Trial Design and Timeline
The Phase I trials will be conducted at two specialized facilities: the Dedov National Medical Research Center (搜索) and Clinical Hospital No. 3 (搜索) in the Yaroslavl region. The clinical trial approval remains valid until the end of 2027, providing Geropharm (搜索) with a substantial timeframe to complete the initial safety and dosing studies.
The drug's active substance is included in Russia's List of Vital and Essential Drugs and accounts for a significant share of the tender market, highlighting its clinical importance in diabetes (搜索) management.
Market Impact and Commercial Significance
According to analytical company Headway (搜索), the market presence of the original Ryzodeg demonstrates substantial commercial potential. Over the 10 months of 2025, Russian government institutions purchased the original drug for a total of 1.19 billion rubles, representing 1.82% of the entire diabetes (搜索) medications market.
The original Ryzodeg has maintained market presence since its 2013 registration in Russia. Manufacturing occurs in Denmark, while packaging and quality control release are performed at Novo Nordisk's facility in Kaluga, indicating the established supply chain that Geropharm (搜索)'s biosimilar aims to compete with.
Parallel Development Programs
Geropharm (搜索)'s diabetes (搜索) biosimilar portfolio extends beyond the combination therapy. In 2025, the Russian Ministry of Health approved Phase III clinical trials for GP40131, a biosimilar of Novo Nordisk's Tresiba (insulin degludec). This study is specifically designed to compare the immunogenicity of the Russian biosimilar with the original drug.
Scientific and Regulatory Considerations
Insulin degludec represents a significant advancement in diabetes (搜索) care as an ultra-long-acting basal insulin analog administered once daily. The compound is a recombinant human insulin with a fatty acid residue attached to lysine, providing extended duration of action.
The immunogenicity studies planned for both biosimilar programs are essential for assessing drug safety. These studies will evaluate whether the biosimilar versions trigger immune responses that could affect efficacy or safety compared to the original formulations.
The dual approach of developing biosimilars for both the single-agent insulin degludec and the combination therapy positions Geropharm (搜索) to address multiple segments of the diabetes (搜索) treatment market, potentially providing more affordable alternatives to patients and healthcare systems.