An expanded FDA approval for both YUFLYMA® (adalimumab-aaty) and its unbranded biosimilar version has been secured by Celltrion, now covering two additional pediatric indications: hidradenitis suppurativa (HS) in adolescents aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older., now covering two additional pediatric indications: hidradenitis suppurativa (HS) in adolescents aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.

This approval significantly broadens the use of the anti-TNFalpha monoclonal antibody, which was previously approved for a range of adult and some pediatric inflammatory conditions, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Adolescent HS and pediatric UV are chronic inflammatory diseases that can impose a substantial burden on young patients and their families, with pediatric UV being a rare, potentially sight-threatening condition, and HS being a chronic skin disease affecting approximately 1-4% of the US population.

The label expansion for YUFLYMA, a high-concentration, citrate-free formulation introduced in the US market in July 2023, demonstrates Celltrion's commitment to advancing high-quality, affordable treatment options and improving broader patient access to care for immune-mediated diseases. Clinicians can now offer YUFLYMA to more patient populations, which is especially critical given the risks associated with adalimumab products, including the potential for serious infections (such as tuberculosis and invasive fungal infections), malignancy (including lymphoma and rare hepatosplenic T-cell lymphoma, particularly in adolescents), and other serious adverse reactions like heart failure and neurologic events. The availability of both branded and unbranded versions, with multiple pricing options, further supports patient affordability for this important treatment.