Interchangeability for Celltrion’s Humira Biosimilar Expanded

FDA has granted an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. Interchangeability now includes a prefilled syringe (40mg) and autoinjectors (40mg and 80mg).

The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription from a healthcare provider. The original Yuflyma BLA was approved 5/2023 for treating eight conditions.

Yuflyma is approved for multiple inflammatory indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis in adult patients. It is also approved for Crohn’s disease in adults and pediatric patients six years of age and older, and juvenile idiopathic arthritis in patients two years of age and older.