On April 14, 2025, Celltrion announced that the FDA designated Yuflyma^® (adalimumab-aaty) as an interchangeable biosimilar of AbbVie’s Humira^® (adalimumab).  Yuflyma^® is a high-concentration (100mg/mL) citrate-free formulation, which accounts for about 85% of adalimumab prescriptions.  Yuflyma^® is the fourth high-concentration Humira^® biosimilar to receive an interchangeability designation.  It was first approved as biosimilar by the FDA on May 23, 2023 and launched July 2, 2023.  It is available in two pricing options, a branded version at a 5% discount to Humira^®’s wholesale acquisition cost (WAC), and an unbranded version at an 85% discount.

According to a Samsung Bioepis Biosimilar Market Q2 2025 Report, Yuflyma^® has gained less than 2% market share.  Humira^® biosimilars overall have gained approximately 23% of the adalimumab market, excluding Sandoz’s Hyrimoz^® (adalimumab-adaz) sold under a private-label through Cordavis, which when last reported in December 2024, had an approximately 12% market share.

There are no ongoing patent disputes related to Humira^® biosimilars.

AbbVie reported net Humira^® revenue of $7.142 billion in the U.S. in 2024.

For more information on these and other biosimilars and biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.