Biopharmaceutical company Celltrion Inc announced on Friday that it has received an expanded interchangeable designation for YUFLYMA (adalimumab-aaty), to now include prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations, from the U.S. Food and Drug Administration (FDA).
YUFLYMA is now fully interchangeable with the reference product, Humira (adalimumab), across all marketed dosage forms and strengths. The product is a high-concentration, citrate-free biosimilar to Humira, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS) and uveitis (UV) in adults, along with Crohn's disease (CD) in adults and children 6 years of age and older and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.
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