The U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations.
With this approval, Yuflyma is now fully interchangeable with the reference product, Humira (adalimumab), across all marketed dosage forms and strengths.
Yuflyma is a high-concentration, citrate-free biosimilar to Humira, approved for multiple inflammatory indications including plaque psoriasis (Ps), hidradenitis suppurativa (HS), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), rheumatoid arthritis (RA), and uveitis (UV) in adult patients; Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.
The interchangeable designation builds on the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab continuously and those who alternated between reference adalimumab and Yuflyma during the dosing interval of Weeks 25-27.
Yuflyma was first introduced in the U.S. market in July 2023 and is currently available as a 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors.
Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet different patient needs and improve patient affordability.
