Celltrion announced on October 17, 2025, that the U.S. FDA has approved label expansions for YUFLYMA® (adalimumab-aaty) and its unbranded counterpart, extending treatment to adolescent hidradenitis suppurativa (HS) in patients aged 12 and older and pediatric uveitis (UV) in children aged 2 and older. Previously approved for adult HS and UV, these new indications mark a significant advancement in managing chronic immune-mediated diseases in younger populations.
Hidradenitis suppurativa is a debilitating, recurrent inflammatory skin disorder affecting 1–4% of the U.S. population, characterized by painful nodules, abscesses, fistulas, and scarring in intertriginous areas. In adolescents, it often disrupts daily life and psychosocial development. Pediatric uveitis, a rare but vision-threatening condition, accounts for 5–10% of all uveitis cases and is frequently asymptomatic, risking complications like cataracts, glaucoma, and amblyopia if untreated.
YUFLYMA, a high-concentration, citrate-free, interchangeable adalimumab biosimilar to Humira®, was first launched in the U.S. in July 2023 and is available in multiple formats (20 mg, 40 mg, 80 mg prefilled syringes; 40 mg, 80 mg autoinjectors), offering flexibility and one of the longest room-temperature stabilities (up to 31 days at 77°F). The unbranded version provides a lower-cost alternative, supporting broader patient access.
“This expansion addresses critical gaps in pediatric care for conditions with profound physical and emotional impacts,” said Dr. Juby Jacob-Nara, Chief Medical Officer at Celltrion USA. Thomas Nusbickel, Chief Commercial Officer, emphasized the approval’s role in strengthening Celltrion’s growing immunology portfolio and improving affordability for high-quality biologics. The safety profile aligns with the known adalimumab class, including risks of serious infections (e.g., TB, invasive fungal), malignancy (including rare HSTCL in adolescents/young adults with IBD), HBV reactivation, demyelinating disorders, and hematologic reactions. Patients require TB screening prior to initiation, and live vaccines are contraindicated. Common adverse events (>10%) include infections, injection-site reactions, headache, and rash.
With these approvals, YUFLYMA is now indicated across nine conditions, including rheumatoid arthritis, juvenile idiopathic arthritis (from age 2), Crohn’s disease (from age 6), and plaque psoriasis. Celltrion continues to lead in biosimilars, with products spanning immunology, oncology, and ophthalmology, reinforcing its commitment to innovative, accessible therapies for U.S. patients.
Link: https://www.celltrion.com/en-us/company/media-center/press-release/4207
