The launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas
KIRKLAND, QC, Canada & SHANGHAI, China – June 23, 2026 – Organon Canada and Shanghai Henlius Biotech, Inc. (2696.HK) today announced that BILDYOS® (denosumab injection) 60 mg/1 mL and TUZEMTY® (denosumab injection) 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, are now available in Canada for all indications of reference products. Used across several indications, denosumab products treat osteoporosis and bone events associated with cancer by helping to strengthen bones. “The approvals represent an important step toward helping broaden access to bone-care treatments in Canada. These biosimilars will introduce additional treatment options across several therapeutic areas, including osteoporosis, which predominantly affects women and impacts 2.3 million Canadians,”1 said Dominic Bégin, President and Managing Director at Organon Canada. “This development reinforces Organon’s commitment to expanding its biosimilar portfolio, improving treatment accessibility, and helping to strengthen the healthcare system while supporting patients in need.” With this launch, Organon reinforces its commitment to offering patients in Canada more treatment options and helping to reduce healthcare costs by increasing access to biosimilars. BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection) have joined Organon’s growing biosimilars portfolio in Canada, which spans five therapeutic areas, including oncology, and includes products with more than nine years of market experience. “The availability of BILDYOS® and TUZEMTY® marks an important step in our collaboration with Organon,” said Darius Panaligan, Chief Commercial Officer, International Markets of Henlius. “Together, we’ve translated our shared vision into tangible outcomes, helping to bring new treatment options to patients in Canada and reinforcing our joint commitment to long-term access.” These product launches reflect Organon’s long-standing commitment to expanding access to cost-effective treatments and advancing women’s health through a patient-centered approach. “The addition of new approved denosumab therapies help reinforce a resilient healthcare system and supports clinicians and patients in navigating osteoporosis treatment options with greater flexibility,” said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection). The agreement covers exclusive global commercialization rights except for China. For more information about these products, including important safety information, visit: BILDYOS_PM-E.pdf and TUZEMTY_PM-E.pdf About Organon
