On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively.
Enoby™ and Xtrenbo™ were approved by the FDA in September 2025. The biosimilars were developed and are manufactured by Gedeon Richter. Under a December 2021 licence and commercialisation agreement, Hikma is responsible for FDA registration and has exclusive rights to commercialise the biosimilars in the US.
In June 2025, Amgen commenced BPCIA litigation against Gedeon Richter and Hikma alleging infringement of 32 US patents relating to denosumab. That litigation was settled in November 2025, with the terms of the settlement providing that Richter/Hikma’s denosumab biosimilars could not be launched in the US before at least 1 January 2026.
A number of denosumab biosimilars have been approved and launched in the US. This includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).