On 13 March 2026, Novartis received FDA approval for Cosentyx® (secukinumab) for the treatment of moderate to severe Hidradenitis Suppurativa (HS) in paediatric patients aged 12 years and older. According to Novartis, Cosentyx® is the only IL-17A inhibitor approved for this age group.
This approval enables earlier intervention for adolescents with HS, who currently have fewer treatment options compared to adults. HS often emerges during adolescence and can cause irreversible damage if left untreated, so this expanded indication is expected to improve patient access and outcomes.
In October 2023, the FDA approved Cosentyx® to treat moderate to severe HS in adults. In the same month, the National Institute for Health and Care Excellence (NICE) in England and Wales recommended Cosentyx® for moderate to severe HS.
There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).