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Top 5 Most-Read Bone Health Articles of 2025
Explore the latest advancements in denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases in 2025.
The denosumab biosimilar market, referencing Prolia and Xgeva, saw rapid regulatory activity and significant legal maneuvering across 2025, expanding treatment options for conditions like osteoporosis and bone metastases. The following are the top five biosimilar bone health news items:
Explore the latest advancements in denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases in 2025.
5. Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
The $3.8 billion market for Prolia/Xgeva (reference denosumab) is poised for significant disruption, with launches for approved biosimilars expected to begin as early as May 31, 2025. Currently, there are 3 FDA-approved denosumab biosimilars and at least 5 additional abbreviated biologics license applications (aBLAs) awaiting FDA approval, including those from Fresenius Kabi, Teva, Organon/Henlius, Accord/Intas, and Gedeon Richter/Hikma. To date, five Biologics Price Competition and Innovation Act (BPCIA) litigations involving 47 patents have been filed. Two major litigations have already settled: Sandoz (manufacturer of Jubbonti/Wyost) settled its case, agreeing to a launch date of May 31, 2025, and Celltrion (manufacturer of Steoboclo/Osenvelt) stipulated to infringement and validity of 29 patents, agreeing to a launch date as early as June 1, 2025. The remaining early-stage cases against Samsung Bioepis, Fresenius Kabi, and Accord were recently consolidated into a Multidistrict Litigation (MDL) in the District of New Jersey (DNJ).
4. FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and the European Medicines Agency (EMA) granted approval to the second pair of denosumab biosimilars (denosumab-dssb; SB16) referencing Prolia/Xgeva. These biosimilars, developed by Samsung Bioepis, were also granted interchangeability designation by the FDA. In the US, the products will be marketed as Ospomyv and Xbryk; Ospomyv is indicated for osteoporosis treatment, and Xbryk is used to prevent skeletal fractures in patients with bone metastases. The approval was supported by clinical data, including a phase 3 study in postmenopausal women with osteoporosis that confirmed equivalent efficacy, as well as comparable safety, immunogenicity, and pharmacodynamics (PD) profiles when compared to the reference denosumab.
3. FDA-Approved SB16 Biosimilar Demonstrates Equivalence to Prolia
New research confirmed that the FDA-approved denosumab biosimilar SB16 (marketed as Ospomyv and Xbryk) is equivalent to the reference product, Prolia, in terms of efficacy for treating postmenopausal osteoporosis (PMO) up to 12 months. The multinational, double-blind, randomized phase 3 study demonstrated that the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12 for the SB16 group was 5.63%, compared to 5.30% for the reference denosumab group, confirming statistically significant equivalence within the predefined margins. Additionally, secondary efficacy measures, including total hip and femoral neck BMD changes, supported equivalence. SB16 also exhibited a safety and immunogenicity profile comparable to denosumab, with hypocalcemia being the most frequently reported adverse event of special interest.
2. FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
The FDA approved another set of denosumab biosimilars, Conexxence and Bomyntra (denosumab-bnht), manufactured by Fresenius Kabi Biopharma, for all indications of the reference products Prolia and Xgeva, respectively. Conexxence is approved for various adult patient populations at high risk for fractures, including osteoporosis, while Bomyntra is approved for indications such as preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. The approval further expands treatment options for bone-related conditions. Fresenius Kabi announced the approval along with a global settlement agreement with Amgen, and plans to launch the biosimilars in the US market mid-2025.
1. FDA Approves Third Pair of Denosumab Biosimilars
The FDA approved Celltrion’s denosumab biosimilars, Steoboclo and Osenvelt (denosumab-bmwo), marking the third approval for a denosumab biosimilar. Steoboclo is approved for all indications of Prolia (osteoporosis patients), and Osenvelt is approved for all indications of Xgeva (for treating and preventing bone fractures in patients at higher risk due to bone metastases). Denosumab is a monoclonal antibody that works by inhibiting the RANKL protein to prevent bone breakdown, thereby strengthening bones and reducing fracture risk. The approval was based on robust evidence from a phase 3 trial that demonstrated equivalence to US-sourced denosumab in improving lumbar spine bone mineral density (BMD) at week 52 in postmenopausal women with osteoporosis. Steoboclo and Osenvelt are anticipated to launch in the US in June 2025, following a settlement agreement with the reference product manufacturer, Amgen.
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