Celltrion Adalimumab Biosimilar Granted Interchangeability Designation

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On April 14, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration granted an interchangeable designation to YUFLYMA (adalimumab-aaty), its biosimilar referencing HUMIRA (adalimumab).  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider.

YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis, which are the same indications for HUMIRA (adalimumab).  As we previously reported, YUFLYMA is available in the U.S. in 20 mg, 40 mg, and 80 mg dosage strengths.

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