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Celltrion’s YUFLYMA Granted Expanded Interchangeable Designation

The biosimilar is now fully interchangeable with Humira across all marketed dosage forms and strengths.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Celltrion’s YUFLYMA (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, YUFLYMA is now fully interchangeable with the reference product, Humira (adalimumab), across all marketed dosage forms and strengths. YUFLYMA is a high-concentration, citrate-free biosimilar to Humira, approved for multiple inflammatory indications i...

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