Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA
Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA
Biosimilars are medicines made to be highly similar to an already approved biological drug produced from living cells, with no meaningful differences in safety or effectiveness. They matter to investors because they introduce lower‑cost competition to expensive biologic treatments—similar to how generic drugs compete with brand drugs—but involve more complex manufacturing, regulatory review and patent risk, which can affect market share, pricing and profit margins across the sector.
denosumabmedical
Denosumab is a laboratory-made antibody medicine that slows bone loss by blocking a natural signal that tells certain cells to break down bone—think of it as applying the brakes to prevent bones from thinning. It is used to treat osteoporosis and to reduce bone complications from cancer, so its regulatory approvals, safety data, patent life and sales performance can materially affect drugmakers’ revenues and investor expectations.
anti–pd-1 mAbmedical
A type of laboratory-made antibody that blocks the PD‑1 protein on immune cells, removing a molecular “brake” that tumors use to hide from the immune system. By reactivating a patient’s own immune response, these drugs can shrink tumors in some cancers; trial results, safety profile and regulatory approvals directly affect a developer’s sales prospects, stock value and acquisition appeal.
antibody-drug conjugates (adcs)medical
Antibody-drug conjugates (ADCs) are advanced medicines that combine a targeted antibody with a powerful drug, acting like a guided missile to deliver treatment directly to cancer cells while sparing healthy tissue. This precision approach can improve effectiveness and reduce side effects, making ADCs a promising area of biotech innovation. For investors, advancements in ADC technology can signal potential growth opportunities in the pharmaceutical and healthcare sectors.
phantom stock unitsfinancial
Phantom stock units are company promises that pay a cash or stock-equivalent award tied to the firm’s share price or value growth, but they do not issue actual shares. Think of them as a bonus check that moves with the stock like a mirror rather than handing over an ownership slice. Investors care because these awards can affect a company’s future cash obligations, executive incentives and reported expenses without causing share dilution.
gmp certificationsregulatory
GMP certifications are formal approvals showing a manufacturer follows Good Manufacturing Practice standards, which ensure products are made consistently, safely, and meet quality controls. Investors care because these certifications lower the risk of product recalls, regulatory penalties, and reputational damage—think of them like a thorough safety inspection for a factory that signals more reliable operations and steadier future revenue.
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The launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas
KIRKLAND, Quebec & SHANGHAI--(BUSINESS WIRE)--
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.
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health, Biosimilars and General Medicines, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. For more information, visit https://www.organon.com/canada-en/ and connect with us on LinkedIn.
About Henlius
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.
Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in 50 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
