South Korea-based biopharmaceutical firm Celltrion has secured the US Food and Drug Administration (FDA) expanded interchangeable designation for Yuflyma (adalimumab-aaty).
The expanded designation now covers all marketed dosage forms and strengths, including prefilled syringes (40mg) and autoinjectors (40mg and 80mg).
It allows Yuflyma to be fully interchangeable with Humira (adalimumab), a disease-modifying antirheumatic drug offered by AbbVie to treat inflammatory conditions.
Yuflyma is a high-concentration, citrate-free biosimilar, approved to treat the same conditions as its reference drug, Humira.
The conditions include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis in adults.
It is also approved for Crohn’s disease in adults and children aged six and above, as well as juvenile idiopathic arthritis in children aged two and older.
Celltrion USA chief commercial officer Thomas Nusbickel said: “This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape.
“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 U.S. biosimilar market, bringing competitive pricing and high-quality, accessible treatment options.”
Yuflyma is a recombinant fully human anti-tumour necrosis factor α (anti-TNFα) monoclonal antibody, available in prefilled syringes (20mg, 40mg, and 80mg) and autoinjectors (40mg and 80mg).
The drug maintains stability at room temperature (25°C) for up to 31 days, offering one of the longest shelf lives in its class.
The expanded designation follows a Phase 3 study that showed comparable pharmacokinetics, efficacy, safety, and immunogenicity between Yuflyma and the reference drug in patients with moderate to severe plaque psoriasis.
The study results were presented at the European Academy of Dermatology & Venereology (EADV) in September 2024, in the Netherlands.
Last year, Celltrion received the European Commission (EC) approval for SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for several chronic inflammatory diseases.
