FDA approves Celltrion's biosimilar Yuflyma
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare (Kosdaq: 068270).
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 USA. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs. Yuflyma will be available to patients in the USA starting July 2023.
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