On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its phase 1 clinical trial protocol for CKD-706, biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab).
According to the report, Chong Kun Dang intends to conduct a European-based clinical trial to demonstrate pharmacokinetic equivalence between CKD-706 and Dupixent® in healthy adults, as well as to assess pharmacodynamics, safety and immunogenicity.
There are a number of dupilumab biosimilars under development. Alvotech and Advanz Pharma entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of dupilumab (among other biosimilars), in Europe and other regions.
In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America. 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.
As reported in November 2025, and confirmed at the J.P. Morgan Health Conference in January 2026, Samsung Bioepis is developing a dupilumab biosimilar. 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.