Celltrion USA launches new dosage for Humira biosimilar
Celltrion USA is offering an 80 mg dose of Yuflyma (adalimumab-aaty), a high-concentration (100mg/ml) and citrate-free formulation of Humira (adalimumab) biosimilar, in the United States.
Yuflyma is used for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody.
Yuflyma is currently available in a single 40-mg dose in both a prefilled syringe with safety guard and autoinjector. The addition of an 80-mg dose will offer more choice and dosage flexibility for patients and clinical practices. Yuflyma 80 mg is offered at the same price as Yuflyma 40 mg to meet the needs of patients, prescribers and payers.
[Read more: Celltrion USA obtains FDA nod for Humira biosimilar]
In addition, a 20-mg dose of Yuflyma is expected to be available in pharmacies in late Q1 2024.
“Yuflyma demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product,” said Thomas Nusbickel, chief commercial officer at Celltrion USA. “These new dose amounts and the auto-injector option provide flexible regimens. These new dose amounts and the 2-step auto-injector option provide flexibility and convenient self-administration.”
[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]