On September 25, 2026, the FDA approved Teva’s Degevma™ (denosumab-adet) as an interchangeable biosimilar of Amgen’s Xgeva^® (denosumab).  Teva’s Ponlimsi™ (denosumab-adet), an interchangeable biosimilar of Amgen’s Prolia^® (denosumab), was approved in March 2026 (previously reported FDA Approves Teva’s Denosumab Biosimilar Ponlimsi™ (denosumab-adet)).  Degevma™ is the tenth FDA-approved Xgeva^® biosimilar.  There are no ongoing patent disputes between Teva and Amgen related to Teva’s denosumab biosimilars and there have not been any publicly announced settlement agreements.

On September 25, 2026, the FDA also approved Emerge / Meitheal’s Yusimry^® (adalimumab-aqvh) as the seventh high concentration biosimilar of AbbVie’s Humira^® (adalimumab) and designated it as interchangeable.  Yusimry^® has been approved as a low concentration biosimilar since December 2021 and launched in July 2023 (previously reported What Do the Humira Biosimilar / Interchangeable Launches Mean for the Adalimumab Market?).  Coherus initially developed Yusimry^® and sold it to Meitheal in June 2024.  According to Samsung Bioepis’s 3Q 2026 Biosimilar Market Report, Yusimry^® has achieved less than a 2% market share.  There are no ongoing patent disputes related to Humira^® biosimilars.

Amgen reported FY25 U.S. sales for Prolia^® of $2.978 billion, and $1.355 billion for Xgeva^®.

AbbVie reported 2025 U.S. sales of 3.062 billion for Humira^®.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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