On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). Dupixent® is also approved in Japan for certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD).
Regeneron and Sanofi continue to roll out new indications for Dupixent®, most recently receiving a positive recommendation by EMA’s CHMP in February 2026 for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU), and FDA approval in the same month for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) where there has been a history of sino-nasal surgery.
Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, and Alvotech and Advanz. 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.