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Accord Announces Commercial Launch of Prolia® / Xgeva® Interchangeable Biosimilars Osvyrti® / Jubereq® (denosumab-desu)

by Robert S. Schwartz, Ph.D.
July 27, 2026

On July 23, 2026, Accord BioPharma announced the commercial launch of Osvyrti® / Jubereq® (denosumab-desu), interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).  Osvyrti® / Jubereq® are the eighth denosumab biosimilars to launch in the U.S.  The launch is pursuant to a consent judgment reached in Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in July 2025 (previously reported Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23).

There are three ongoing litigations related to denosumab biosimilars, including Alvotech / Dr. Reddy’s AVT03 (denosumab) (Case No. 1:25-cv-17277 (D.N.J.)  / MDL 1:25-md-03138 (D.N.J.)), Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) (Case No. 1:25-cv-17278 (D.N.J.)  / MDL 1:25-md-03138 (D.N.J.)), and Alkem / Enzene’s ENZ215 (denosumab) (Case No. 1:25-cv-17596 (D.N.J.)  / MDL 1:25-md-03138 (D.N.J.)).

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

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.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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