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Celltrion Secures US Interchangeability for Biosimilar Adalimumab Yuflyma®

Apr 14, 2025

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty).

Celltrion’s high concentration formulation was first approved by the FDA in May 2023, and the company applied for interchangeable status in January 2024.

The first high concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita™, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.