On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) and inadequate response to histamine-1 antihistamine (H1AH) treatment. This approval is the fifth indication of Dupixent® for young children in the US and follows EU approval for the same indication earlier this month.
Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz and Binnopharm and Mabwell. 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 January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).