Celltrion, Inc. has announced that the US Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA (adalimumab-aaty), now including prefilled syringes (40mg) and autoinjectors (40mg and 80mg) presentations. 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 six years of age and older; and juvenile idiopathic arthritis (JIA) in patients two 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 Chief Commercial Officer at Celltrion USA, Thomas Nusbickel. "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. Going forward, Celltrion will continue to put patients first by keeping drug costs affordable and remaining at the forefront of the US biosimilar market, bringing competitive pricing and high-quality, accessible treatment options,” added Nusbickel.

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. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV), in September 2024, in the Netherlands. 

The expanded interchangeability designation for YUFLYMA is complemented by a strategic price reduction that reflects Celltrion's ongoing commitment to improving patient access while aligning with federal efforts to lower drug prices. Effective immediately, the wholesale acquisition cost (WAC) list price of YUFLYMA has been reduced to USD 948 per syringe, and the updated pricing has been uploaded to the national pricing compendia.

YUFLYMA was first introduced in the US 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.