Celltrion has announced that the US Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.

YUFLYMA was previously approved by the FDA as a biosimilar to Humira for multiple indications, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The latest approval extends its use to pediatric and adolescent populations for HS and UV, both of which were earlier approved for adult patients only.

HS is a chronic and recurrent inflammatory skin condition marked by painful nodules, abscesses, comedones, fistulas, sinus tracts, and scarring in intertriginous areas, often affecting the quality of life of adolescents. Pediatric UV, a potentially sight-threatening eye disorder accounting for up to 10 percent of all uveitis cases, can lead to severe complications such as cataract, glaucoma, and amblyopia in pediatric patients,  if left untreated.

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, said, "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.”

First introduced in the US in July 2023, YUFLYMA is available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution in autoinjectors. Celltrion offers both branded and unbranded versions of adalimumab-aaty, providing two pricing options aimed at improving affordability and patient access.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, added, "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."