Celltrion USA Announces U.S. FDA Approval of Yuflyma® (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira® (adalimumab) Biosimilar

Thursday, May 25, 2023

Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.1

Yuflyma is Celltrion’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.”

“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.

The approval of Yuflyma was based on a comprehensive data package of analytical, preclinical, and clinical studies, demonstrating that Yuflyma is comparable to the reference product in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and one year following treatment.



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