The FDA has approved expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and its unbranded version, authorizing treatment of adolescent hidradenitis suppurativa (HS) in patients aged 12 years and older and pediatric uveitis (UV) in patients aged 2 years and older.
Celltrion, Inc., the manufacturer of YUFLYMA, stated that the new indications extend the approved uses of the adalimumab biosimilar beyond adults to include pediatric and adolescent populations with these chronic inflammatory conditions. HS affects approximately 1–4% of people in the United States and is characterized by painful, inflamed nodules and abscesses, while pediatric uveitis—representing 5–10% of all uveitis cases—can lead to significant ocular complications including cataracts and glaucoma.
YUFLYMA is a high-concentration, citrate-free, and interchangeable biosimilar to Humira®, previously approved for rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and adult HS and UV.
The expanded pediatric labeling underscores Celltrion’s broader immunology portfolio in the U.S., emphasizing improved access to affordable biologic therapies. YUFLYMA is available in 20 mg, 40 mg, and 80 mg prefilled syringes and 40 mg and 80 mg autoinjectors, with both branded and unbranded forms offered under different pricing models to enhance affordability.
According to Celltrion executives, the FDA’s latest decision aligns with efforts to expand biosimilar adoption and provide additional treatment options for children and adolescents living with immune-mediated diseases.
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