FDA Approves Expanded Indications for Adalimumab-Aaty for Pediatric Indications

The FDA approved an expanded indication for adalimumab-aaty (Yuflyma) and the unbranded version to include the treatment of hidradenitis suppurativa (HS) for patients 12 years and older and uveitis (UV) for patients 2 years and older.

"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. It impacts patients physically and also emotionally and socially,” Juby Jacob-Nara, MD, DHSc, MPH, MBA, senior vice president and chief medical officer at Celltrion USA, said in a news release.¹ "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."

HS is a chronic inflammatory skin condition that affects the apocrine gland-bearing areas, which include the axillae, groin, and buttocks. According to the American Academy of Pediatrics, nearly one-third of cases occur in pediatric patients, and nearly half of patients’ initial symptoms begin in childhood. It is characterized as painful nodules and abscesses that occur in the skin folds and eventually form scarring. Furthermore, studies have shown that the gap between onset of disease and age of diagnosis is nearly 2 years due to delayed diagnosis. The early disease is commonly missed or confused with infections, according to the organization.²

UV’s diagnosis and management are particularly challenging and are typically less common in children compared with adults, according to a review published in the Journal of Ophthalmic and Vision Research. Diagnosis for UV is also often delayed because younger children can be asymptomatic or unable to express complaints. Even in advanced cases, parents and health care providers may not be aware of the severity of the visual impairment until the development of visible changes, such as band keratopathy, strabismus, or leukocoria.³

Previously, the biosimilar for adalimumab (Humira) was approved for a variety of indications, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis. Both HS and UV were indications for adult patients.¹

The biosimilar was first introduced into the US market in July 2023, and it is currently available as 20 mg, 40 mg, and 80 mg solutions in prefilled syringes and 40 mg and 80 mg for autoinjectors.¹

In May 2025, the FDA also granted expanded interchangeability designation for the biosimilar to include the prefilled syringes and autoinjectors across marketed dosage formulas and strengths. The initial interchangeability designation was granted in early April 2025, which included many of the inflammatory indications of adalimumab.⁴

"The expansion of pediatric indications for Yuflyma highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the news release.¹ "The approval of pediatric indications for Yuflyma and unbranded adalimumab-aaty strengthens our growing immunology portfolio and supports broader patient access to high-quality, affordable treatments."

READ MORE: FDA Updates Resource Center

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REFERENCES

1. FDA approves expanded pediatric indications for Yufylma (adalimumab-aaty) and unbranded adaliumab-aaty in the United States. News release. Celltrion USA. October 17, 2025. Accessed October 17, 2025. https://prnmedia.prnewswire.com/news-releases/fda-approves-expanded-pediatric-indications-for-yuflyma-adalimumab-aaty-and-unbranded-adalimumab-aaty-in-the-united-states-302587319.html

2. Cotton CH, Chen SX, Hussain SH, Lara-Corrales I, Zaenglein AL. Hidradenitis suppurativa in pediatric patients. Pediatrics. May 2023; 151(5):e2022061049. doi:10.1542/peds.2022-061049

3. Tugal-Tutkun I. Pediatric uveitis. J Ophthalmic Vis Res. 2011;6(4):259-269.

4. Gallagher A. FDA grants expanded interchangeability Designation to Yuflyma. Drug Topics. May 23, 2025. Accessed October 17, 2025. https://www.drugtopics.com/view/fda-grants-expanded-interchangeability-designation-to-yuflyma