Celltrion's Yuflyma gains interchangeable biosimilar designation

The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s (NYSE: ABBV) mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis.

Developed by South Korean firm Celltrion (Kosdaq: 068270), Yuflyma is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory indications. The biosimilar first gained FDA approval in May 2023, at which time Celltrion said it would also seek an interchangeability designation.

FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws