Xgeva (Amgen) has faced US biosimilar competition since 2025. Amgen's US patents expired in February 2025 and denosumab biosimilars launched later that year. Prevents bone complications in cancer.
Xgeva's US exclusivity date is based on generics launched. US biosimilars have already launched, so the loss of exclusivity is under way. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
Among past biologics facing biosimilars: Humira's US sales fell to 65% of their 2022 level in its first full year of biosimilars (2023) and 16% two years later; Stelara's US sales fell to 57% of their 2024 level in its first full year of biosimilars (2025). See how past cliffs played out →
Copies on the US market The FDA has approved Xgeva biosimilars from 9 companies, most sold alongside their Prolia versions; launches began in 2025 after Amgen's US patents expired in February.
| Company (product) | Stage |
|---|---|
| Sandoz (Wyost) | FDA-approved biosimilar |
| Samsung Bioepis (Xbryk) | FDA-approved biosimilar |
| Celltrion (Osenvelt) | FDA-approved biosimilar |
| Fresenius Kabi (Bomyntra) | FDA-approved biosimilar |
| Henlius (Bilprevda) | FDA-approved biosimilar |
| Biocon Biologics (Aukelso) | FDA-approved biosimilar |
| Hikma (Xtrenbo) | FDA-approved biosimilar |
| Accord BioPharma (Jubereq) | FDA-approved biosimilar |
| Amneal (Oziltus) | FDA-approved biosimilar |
From the FDA's own approval lists; FDA approval does not always mean a product has launched. Checked September 2026. Sources: FDA Purple Book · Amgen 10-K 2025
Xgeva is 5.7% of Amgen's 2025 revenue ($2.1B of $36.8B). With Prolia, Otezla, Repatha and Enbrel, the drugs tracked here add up to 38% of Amgen's revenue losing US exclusivity by 2029.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Xgeva is highlighted.