On 24 February 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. Dupixent® is the first and only treatment approved for AFRS in the US.
There are a number of companies with dupilumab biosimilars under development. For example, Alvotech is developing AVT19 (dupilumab), and has entered into partnership agreements with Advanz in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.
In January 2026, it was announced that Samsung Bioepis had added a dupilumab biosimilar to its pipeline. In the same month, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab). CSPC Pharmaceutical had earlier 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. It was also reported in December 2025 that Russia’s Binnopharm Group and China’s Mabwell signed a MOU in relation to localising the production of Mabwell’s dupilumab biosimilar in Russia and the EAEU.