U.S. License Holder:
Celltrion
Date of License:
May-23-2023 (High Concentration, Interchangeable)
Last Update:
Oct-31-2025
FDA-Approved Indications
YUFLYMA (adalimumab-aaty) is a tumor necrosis factor (TNF) blocker indicated for treatment of:
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis;
Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older;
Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis;
Reducing signs and symptoms in adult patients with active ankylosing spondylitis;
Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;
Treatment of moderately to severely active ulcerative colitis in adults patients;
Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate;
Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older;
Treatment of non-infectious intermediate, posterior and panuveitis in adults and pediatric patients 2 years of age and older.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Yuflyma® (high-concentration) (Celltrion) (December-2021)
Biosimilars Approved In The E.U.
Yuflyma® (high-concentration) (Celltrion) (February-2022)Yuflyma® (low-concentration) (Celltrion) (February-2021)
Biosimilars Approved In Australia
Yuflyma® (Celltrion) (February-2022)
Biosimilars Approved In South Korea
Yuflyma® (high-concentration) (Celltrion) (October-2021)
