On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). On February 15, 2025, Samsung Bioepis announced the biosimilars had also been approved in the E.U. under the trade names Obodence™ / Xbryk™.
This approval follows Sandoz’s Jubbonti® / Wyost® (denosumab-bbdz), approved as interchangeable with Prolia® / Xgeva® in March 2024. At least six other aBLAs for denosumab biosimilars remain pending at the FDA, including Celltrion’s CT-P41 (submitted in November 2023), Fresenius Kabi’s FKS518 (accepted in May 2024), Teva’s TVB-009P (accepted in October 2024), Organon / Shanghai Henlius Biotech’s HLX14 (accepted in October 2024), Accord / Intas’s INTP23 (undisclosed filing date prior to November 2024), and Gedeon Richter / Hikma’s RGB-14 (denosumab) (accepted in December 2024).
Samsung Bioepis is involved in a BPCIA litigation related to Ospomyv™ / Xbryk™, Case No. 1:24-cv-08417 (D.N.J.), which was consolidated into a multidistrict litigation (MDL1:25-md-03138 (D.N.J.)) on February 6, 2025, along with Amgen’s denosumab biosimilar cases against Fresenius Kabi (1:25-cv-01080 (D.N.J.)) (transferred from 1:24-cv-09555 (N.D. Ill.)) / MDL 1:25-md-03138 (D.N.J.)) and Accord (1:25-cv-01305 (D.N.J.)) (transferred from 5:24-cv-00642 (E.D.N.C.) / MDL 1:25-md-03138 (D.N.J.)). Amgen v. Celltrion (1:24-cv-06497 (D.N.J.)) / MDL 1:25-md-03138 (D.N.J.)) was also included in the MDL, however it recently reached a consent injunction (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation) and, therefore, coordinated proceedings with the other cases may be more limited.
Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.
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The author would like to thank April Breyer Menon for her contributions to this article.
