On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally interchangeable biosimilars Bosaya™ / Aukelso™ (denosumab-kyqq), which were approved by the FDA on September 16, 2025. The settlement allows Biocon to launch Bosaya™ / Aukelso™ from October 1, 2025. Additional terms of the settlement agreement have not been publicly disclosed.
This is the sixth settlement related to Prolia® / Xgeva® biosimilars. Previous settlements include Amgen v. Sandoz, Case No. 1:23-cv-02406 (D.N.J.) in April 2024 related to interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Celltrion, Case No. 1:24-cv-06497 (D.N.J.) in January 2025 related to Stoboclo® / Osenvelt® (denosumab-bmwo) (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Fresenius Kabi, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in March 2025 related to Conexxence™ / Bomyntra™ (denosumab-bnht) (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement); Amgen v. Accord, Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in July 2025 related to INTP23 (previously reported Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23); and Amgen v. Samsung Bioepis, Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.) in September 2025 related to Ospomyv™ / Xbryk™ (denosumab-dssb) (previously reported Amgen and Samsung Bioepis Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation).
Sandoz’s biosimilars were launched in June 2025, and Celltrion and Fresenius Kabi’s biosimilars launched in July 2025 (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars; Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®). Under the settlement agreement with Accord, INTP23 will be able to launch once it is FDA approved.
Two lawsuits for Prolia® / Xgeva® biosimilars remain pending: Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde) (Case No. 1:25-cv-12152 (D.N.J.)) and Shanghai Henlius Biotech / Organon’s Bildyos® / Bilprevda® (denosumab-nxxp) (Case No. 1:25-cv-12160 (D.N.J.)).
Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.
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The authors would like to thank April Breyer Menon for her contributions to this article.
