SILVER SPRING, Md. — The Food and Drug Administration has approved expanded indications for Celltrion's Yuflyma (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescents 12 and older, and uveitis (UV) in pediatric patients 2 and older.
The FDA previously approved Yuflyma as a biosimilar to Humira for a variety of indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps). HS and UV were previously approved in adult patients, and the latest approval expands these two indications to include pediatric and adolescent populations.
HS, which affects approximately 1%-4% of people in the U.S., is a chronic, inflammatory, recurrent skin condition characterized by painful nodules, abscesses, comedones, fistulas, sinus tracts, and scarring in intertriginous areas. Adolescent HS shares similar clinical features and often disrupts school and daily life. Pediatric UV, a potentially sight-threatening eye condition that accounts for 5% to 10% of all uveitis cases, is frequently asymptomatic in children and can become chronic or may have significant morbidities in pediatric patients, such as cataract, glaucoma, and amblyopia.
"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," said Celltrion USA senior vice president and chief medical officer Dr. Juby Jacob-Nara. "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."
Yuflylma was first introduced in the U.S. in July 2023 and is currently available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet differing patient needs and improve patient affordability.
"The expansion of pediatric indications for Yuflyma highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "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."
Yuflyma is a high-concentration, low-volume and citrate-free adalimumab biosimilar. It is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. It features one of the longest shelf lives in its class, maintaining stability at room temperature (77 °F, 25 °C) for up to 31 days.
