On 8 December 2025, GxP News reported that Russia’s Binnopharm Group and China’s Mabwell have signed a MOU in relation to localising the production of Mabwell’s biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab) in Russia and the EAEU.
The two companies have previously partnered in 2022, with Binnopharm Group obtaining the exclusive rights for the production, registration and sale of Mabwell’s adalimumab and denosumab biosimilars (9MW0113, 9MW0321 and 9MW0311) in Russia and the EAEU. In January 2024, Mabwell’s adalimumab and denosumab biosimilars were approved for Phase III clinical trials in Russia, where Russian clinical data is required for local marketing, with Binnopharm to conduct and fund the trials.
There are a number of dupilumab biosimilars under development. A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar. In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection. In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.
Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.