Added FDA approval for Celltrion’s Yuflyma

26 May 2025

The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations.

Developed by South Korean firm Celltrion (Kosdaq: 068270), with this approval, Yuflyma is now fully interchangeable with the reference product, AbbVie’s (NYSE: ABBV) mega blockbuster Humira (adalimumab), across all marketed dosage forms and strengths.

In 2024, Humira recorded sales of $8.99 billion, with around 79% of these originating from the USA, underscoring its market dominance.

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