New Biosimilar Treatments
Organon Canada and Henlius launch two denosumab biosimilars, boosting treatment access and reducing costs.
Organon Canada and Shanghai Henlius Biotech have launched two new denosumab biosimilars — BILDYOS® and TUZEMTY® — in Canada, as of June 23, 2026, according to Business Wire. The products are biosimilars to Amgen's PROLIA and XGEVA, two widely used bone-health drugs. Organon's Canadian president Dominic Bégin said the launch "will introduce additional treatment options across several therapeutic areas, including osteoporosis, which predominantly affects women and impacts 2.3 million Canadians."
The launch brings Organon Canada's biosimilar portfolio to eight products across five therapeutic areas, according to Business Wire. It also marks a key milestone in the 2022 global licensing deal between Organon and Henlius, which was valued at up to $541 million.
Health Canada Approved Both Drugs in March 2026
Health Canada officially approved BILDYOS® and TUZEMTY® on March 24, 2026, for all the same uses as PROLIA and XGEVA. The approval covered treating postmenopausal osteoporosis, bone loss from cancer treatment, and bone complications from tumors. Health Canada confirmed the biosimilars are "highly similar" to the reference drugs in structure, biological activity, and efficacy.
A biosimilar is a near-identical copy of a biologic drug — a medicine made from living cells. Once patents expire on the original drug, biosimilars can enter the market at lower prices. BILDYOS comes in a 60 mg/mL dose, mirroring PROLIA. TUZEMTY comes in a 120 mg/1.7 mL dose, mirroring XGEVA.
A $541 Million Partnership Built to Reach Global Markets
The roots of this launch go back to June 2022, when Organon and Shanghai Henlius signed a licensing and supply deal. Organon paid $73 million upfront and agreed to additional milestone payments, for a total deal value of up to $541 million, according to Business Wire. The deal gave Organon exclusive rights to sell Henlius's denosumab biosimilar in all markets outside China, including the U.S., EU, and Canada.
Henlius had been developing the drug since at least May 2020, when China's drug regulator approved early-stage trials. The European Commission approved BILDYOS and its EU counterpart BILPREVDA in September 2025. The U.S. FDA accepted the application in October 2024, and a decision there is still pending. Henlius's Chief Commercial Officer Darius Panaligan called the Canadian launch a "tangible outcome" of the two companies' shared vision.
Osteoporosis Patients Stand to Gain the Most From Lower-Cost Options
Osteoporosis affects 2.3 million Canadians, and the disease disproportionately hits older women. Dr. Famida Jiwa, President and CEO of Osteoporosis Canada, said the new approvals give clinicians and patients "greater flexibility" in managing treatment, according to Montreal Gazette. Biosimilars typically cost 20% to 50% less than the original biologic drug.
Biologics made up 38.6% of all pharmaceutical sales in Canada in 2023 — well above the OECD median of 30.1%. Total biologic sales hit $15 billion that year, up 19.9% from the year before. Provinces like Ontario, British Columbia, and Quebec have already moved to require patients to switch from originator biologics to biosimilars to keep their public drug coverage.
Organon Enters a Market Already Being Contested by Sandoz
Organon is not the first company to bring a denosumab biosimilar to Canada. Sandoz won approval for its versions, called Wyost and Jubbonti, in 2024. Organon's entry adds more competition and should push prices lower. Analysts at Pearce IP note that Apotex and Biocon are also expected to enter the Canadian market within a similar window, raising questions about long-term pricing pressure on all biosimilar makers.
Meanwhile, Amgen — the maker of the original PROLIA and XGEVA — has historically used patent filings and legal challenges to slow biosimilar competition, a practice critics call "evergreening." Michael Casia, who chairs Biosimilars Canada and previously led Organon Canada, has publicly pushed regulators to address tactics he says "unjustly curtail" competition and delay savings for patients and the healthcare system.
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