Celltrion’s Yuflyma (biosimilar, adalimumab) Receives the US FDA’s Approval for Multiple Indications


The US FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira for the treatment of 8 conditions: RA, JIA, PsA, AS, CD, UC, PsO, and HS. Yuflyma is a high-concentration (100mg/mL) & a citrate-free adalimumab biosimilar
The approval was based on a comprehensive data package of preclinical, clinical, and analytical studies which showed that the biosimilar and reference products were similar with regard to efficacy, safety, PK, and immunogenicity after 24wks. and 52wks. of treatment
Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes. The product is expected to be available in July 2023 in the US

Ref: Businesswire | Image: Celltrion

Related News:- Celltrion Launches Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Disease in Canada

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