On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, across all reference indications.
Under a June 2022 agreement, Organon has exclusive global commercialisation rights for Henlius’ denosumab (and pertuzumab) biosimilars in Canada and other countries, “except for China; including Hong Kong, Macau and Taiwan”. Organon expects to launch the denosumab biosimilars in Canada later in 2026.
Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025). Bildyos® and Bilprevda® were approved in the EU in September 2025.
Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024) were the first biosimilars approved in Canada, and were launched in August 2024. This was followed by the Canadian approval of Celltrion’s Stoboclo® and Osenvelt® in September 2025.