The FDA has approved adalimumab-aaty (YUFLYMA; Celltrion, Inc.) for the treatment of adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV) in the U.S. This approval, which covers both YUFLYMA and its unbranded version, expands access to affordable treatment options for children and adolescents living with chronic immune-mediated diseases.
Expanding Access to Meet Patients’ Needs
“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, MD, MPH, senior vice president and chief medical officer at Celltrion USA. “It impacts patients physically and also emotionally and socially.”
With this label expansion, more patient populations will now have access to adalimumab-aaty for multiple immune-mediated diseases, including psoriatic arthritis, plaque psoriasis, and rheumatoid arthritis, in addition to HS and uveitis in adults, now in pediatric populations as well.
Additional Indications Address a Wider Range of Conditions
Hidradenitis suppurativa is a chronic, progressive inflammatory disorder that often begins after puberty. Inflammation leads to abscesses, nodules, comedones, fistulas, sinus tracts, and scarring in intertriginous areas. Affecting approximately 1–4% of the U.S. population, HS can significantly disrupt school and daily life for adolescents.
Pediatric uveitis, a group of inflammatory conditions affecting the middle layer of the eye, is less common than adult uveitis, accounting for 5-10% of all uveitis cases. However, it remains a leading cause of childhood blindness. Often asymptomatic in early stages, pediatric uveitis can lead to serious ocular morbidity if left untreated.
Adalimumab-aaty, a fully interchangeable biosimilar to Humira, is approved across all dosage forms and strengths. It had previously been authorized for multiple inflammatory conditions in adults, including psoriatic arthritis, plaque psoriasis, and rheumatoid arthritis.
Why This Approval Matters
Thomas Nusbickel, chief commercial officer at Celltrion USA, described the approval as a reflection of the company’s ongoing commitment to meeting unmet needs across immune-mediated diseases.
“The approval of pediatric indications for YUFLYMA and unbranded adalimumab-aaty strengthens our growing immunology portfolio,” he said, “and supports broader patient access to high-quality, affordable treatments.”
This milestone brings good news for patients living with chronic immune-mediated diseases and the specialists who treat them, underscoring dermatology’s role on the frontline of chronic inflammatory disease management.
The recognition of adalimumab-aaty for these expanded indications ensures that more children and adolescents have access to safe, effective, and affordable therapies—helping to close care gaps for those living with serious, disruptive conditions like adolescent HS and pediatric uveitis.
