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Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®

by Robert S. Schwartz, Ph.D.
July 15, 2025

On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA litigation No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement).  Conexxence™ / Bomyntra™ were FDA-approved March 25, 2025, shortly after the settlement (previously reported Prolia® / Xgeva® Biosimilar Updates: Alvotech / Dr. Reddy’s AVT03 aBLA Acceptance, Fresenius Kabi’s Conexxence™ / Bomyntra™ FDA-Approval).

On July 7, 2025, Celltrion announced the launch of Stoboclo® / Osenvelt® (denosumab-bmwo), also pursuant to a settlement agreement resulting from BPCIA litigation No. 1:24-cv-06497 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation).  Stoboclo® / Osenvelt® were approved by the FDA on February 28, 2025 (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement).

These denosumab biosimilar launches come after Sandoz launched its interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) in June 2025 at a 14% discount (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars).

The denosumab market is one to watch in that it is rather unique for biosimilar launches to date, with numerous interchangeables and biosimilars launching within weeks of one another.  There are many other biosimilars awaiting launch, including Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb), approved as interchangeable in February 2025 (litigation ongoing- Case No. 1:24-cv-08417 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)), and at least 7 pending aBLAs at the FDA.  Many of these biosimilars are currently involved in BPCIA litigations, including those from Hikma, Shanghai Henlius Biotech, and Biocon, which just began at the end of June (previously reported Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed Biosimilars).

Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.

For an overview of Prolia® / Xgeva® patent proceedings and aBLAs, please visit Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo® / Osenvelt® (denosumab-bmwo) / Conexxence™ / Bomyntra™ (denosumab-bnht).  For more information about these and other 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.

    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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