Indication expansions include hidradenitis suppurativa for patients 12 years and up, as well as for patients with uveitis aged 2 years and older.
FDA expands adalimumab-aaty's pediatric indications to include hidradenitis suppurativa, uveitis | Image credit: Contemporary Pediatrics
On October 17, 2025, the FDA approved expanded indications for Celltrion's adalimumab-aaty (Yuflyma), and its unbranded version, to include treatment for patients with hidradenitis suppurativa (HS) aged 12 years and older, and patients with uveitis aged 2 years and up, according to a press release from the company.1
The expanded indications add to several previously approved indications for adalimumab as a biosimilar to Humira (AbbVie), which are listed below.
HS affects approximately 1–4% of the US population and is characterized by painful nodules, abscesses, and sinus tract formation in intertriginous areas. Adolescent HS presents similarly to adult disease and is associated with significant disruptions to school attendance and daily life.
Pediatric UV accounts for 5–10% of all uveitis cases and may progress silently in children. If untreated, it can result in severe complications, including cataract, glaucoma, and vision loss.
“Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers,” said Juby Jacob-Nara, senior vice president and chief medical officer at Celltrion USA, in the press release. “With this label expansion, YUFLYMA is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians."
Adalimumab-aaty was first launched in the United States in July 2023 and is available in multiple formulations:
“Expanding pediatric indications for YUFLYMA highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases,” said Thomas Nusbickel, chief commercial officer at Celltrion USA. “This approval strengthens our immunology portfolio and supports broader patient access to high-quality, affordable treatments.”
Adalimumab-aaty is a high-concentration, citrate-free biosimilar of adalimumab, a recombinant, fully human monoclonal antibody targeting tumor necrosis factor alpha (TNFα). By inhibiting TNFα, YUFLYMA modulates inflammatory pathways involved in a range of autoimmune and inflammatory disorders.
The product has also been designated by the FDA as an interchangeable biosimilar, meaning it can be substituted for Humira at the pharmacy level. It features one of the longest room-temperature shelf lives among adalimumab products, maintaining stability for up to 31 days at 77°F (25°C).
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