On March 18, Novartis announced that secukinumab has received FDA approval for a new indication in the United States for the treatment of moderate to severe hidradenitis suppurativa (HS) in children aged 12 years and older . Screenshot source: Official WeChat account of the company
Secukinumab is the world’s first approved fully human interleukin (IL)-17A inhibitor that can specifically neutralize IL-17A from multiple sources and inhibit its pro-inflammatory effects.
On December 26, 2014, the drug was first approved globally in Japan, and subsequently approved for marketing in the European Union and the United States in January 2015. It entered the Chinese market for the first time in 2019. Currently, the drug has been approved globally for multiple indications, including hidradenitis suppurativa, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis.
This approval for secukinumab in patients aged 12 years and older with moderate to severe hepatitis B (HS) weighing over 30 kg is based on rigorously designed adult studies, pharmacokinetic models extrapolated from adult HS and psoriasis clinical trials, and data from other approved pediatric clinical trials. The approval is also supported by dose analysis, which predicts that weight-based dose adjustment of secukinumab in pediatric patients can achieve similar drug exposure to adult HS patients.As a blockbuster drug in the autoimmune field, secukinumab achieved sales of $1.128 billion in 2016 since its initial approval in December 2014. It is projected to reach a new high of $6.668 billion globally by 2025 , representing a year-on-year increase of 8.58%. This success is undoubtedly attributed to the broad prospects of the IL-17A target in the autoimmune field. Secukinumab is still expanding its approved indications until the end of 2023.However, secukinumab undoubtedly faces fierce market competition.From the perspective of biosimilars, Insight database shows that six biosimilars have entered the clinical stage globally . The fastest is Bio-Thera Solutions' BAT2306 , which was submitted for market approval in February 2025 and has reached overseas agreements with four companies targeting different overseas markets ; CSPC Pharmaceutical Group's SYS6012 , Mabpharm's CMAB015 , and Certified Pharmaceuticals ' CT-P55 are also in Phase III clinical development.From a target perspective, besides secukinumab, there are currently six other IL-17A monoclonal antibodies approved for marketing globally , from 3SBio ( Amukitabine ) , Zhixiang Jintai (Celicizumab ) , and Hengrui Medicine (…).
These include funacizumab , UCB ( bicizumab) , Eli Lilly ( ixicizumab) , and five others that are currently under review for market approval.
Currently approved IL-17A monoclonal antibody drugs include Eli Lilly's Ixekizumab, used for moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis; and Bimekizumab, which is approved for the treatment of psoriasis.
Among the IL-17A monoclonal antibody drugs under development, those that are progressing relatively quickly include Akeso Biopharma's Gumochi monoclonal antibody (AK111), Junshi Biosciences' JS005, and Livzon Pharmaceutical's LZM012 (XKH004).

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