On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.
Bildyos® and Tuzemty® (HLX14) were approved in Canada in March 2026. Organon was granted the exclusive commercialisation rights to Henlius’ denosumab biosimilars globally, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 agreement.
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® (February 2024) and Jubbonti® (March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024. This was followed by the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025), Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, (April 2026) and Biocon’s Bosaya™ and Vevzuo™ (April 2026).