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Celltrion Launches US Pediatric High Concentration Adalimumab Biosimilar

Mar 28, 2024

On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg dose launched in January 2024 and a 40mg dose, first approved by the FDA in May 2023, launched last year.  All dosage forms are the high concentration formulation of adalimumab (100mg/mL).

Earlier this year, Celltrion applied to the FDA seeking interchangeable status for Yuflyma®.  Celltrion has previously said that it “tentatively expects” interchangeability designation to be granted in Q4 2024.