FDA Approves Adalimumab-aaty (Yuflyma) Pediatric Indications in Hidradenitis Suppurativa, Uveitis

Celltrion has announced the US Food and Drug Administration (FDA) approval of expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients ≥ 12 years of age and uveitis (UV) in pediatric patients ≥ 2 years of age.1

"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, Senior Vice President and Chief Medical Officer at Celltrion USA, said in a statement.1 "With this label expansion, [adalimumab] is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians."

Adalimumab-aaty is a high-concentration, low-volume and citrate-free adalimumab biosimilar approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, HS, and UV. Of note, the latest approval expands the indications for HS and UV to include pediatric and adolescent populations.1

The recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. First introduced in the US market in July 2023, its April 2025 interchangeable designation was supported by data from the phase 3 interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab continuously and those who alternated between reference adalimumab and adalimumab-aaty during the dosing interval of week 25-27.2

On May 23, 2025, the FDA granted an expanded interchangeable designation for adalimumab-aaty to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations, making it fully interchangeable with the reference product, adalimumab (Humira), across all marketed dosage forms and strengths. Currently, adalimumab-aaty is available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors.3

As described in the release from Celltrion, the Company offers adalimumab-aaty in both branded and unbranded versions, with 2 pricing options to meet differing patient needs and improve patient affordability.1

"The expansion of pediatric indications for [adalimumab-aaty] 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 a statement.1 "The approval of pediatric indications for [adalimumab-aaty] and unbranded adalimumab-aaty strengthens our growing immunology portfolio and supports broader patient access to high-quality, affordable treatments."

References

1. Celltrion. FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States. October 17, 2025. Accessed October 17, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4207

2. Celltrion. U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). April 14, 2025. Accessed October 17, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3894?page=1&searchWord=adalimumab-aaty&selectType=

3. Celltrion. Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths. May 23, 2025. Accessed October 17, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3981?page=1&searchWord=adalimumab-aaty&selectType=