On 13 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the European Commission for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihistamines and who are naive to IgE therapy for CSU. The approval follows a positive CHMP opinion for the indication in February 2026.
The existing CSU indication in Europe (approved in November 2025) had covered adults and adolescents (12 years and above). According to Regeneron, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.
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.