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Celltrion USA obtains FDA nod for Humira biosimilar

Yuflyma is FDA-approved to treat eight conditions, including Crohn’s disease and ulcerative colitis.
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Celltrion USA has received the Food and Drug Administration’s permission for Yuflyma (adalimumab-aaty), a high-concentration (100 mg/ml) and citrate-free formulation of Humira (adalimumab) biosimilar. The FDA approved treating eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. 

Yuflyma is Celltrion USA's fifth biosimilar and second anti-TNF biosimilar approved for use in the United States. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs. 

“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice,” said Tom Nusbickel, chief commercial officer at Celltrion USA. “As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients.”

[Read more: Fresenius Kabi receives FDA approval for Humira biosimilar]

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Professor Jonathan Kay of UMass Chan Medical School.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

Yuflyma will be available to patients in the United States starting in July 2023.

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