The U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Celltrion’s 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 rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), 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.

“This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “In alignment with recent federal initiatives aimed at lowering drug costs, we’ve taken timely action to enhance patient access and affordability. YUFLYMA – a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira – reflects our long-standing commitment to delivering high-quality, accessible treatment options.”

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 (ADA) continuously and those who alternated between reference ADA 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.