Apotex Strengthens Osteoporosis Care in Canada with Health Canada's Approval of DENOZA™, a Denosumab Biosimilar
Apr 7, 2026Toronto, ON – April 7, 2026 – Apotex Inc. ("Apotex" or the "Company"), the largest Canadian based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications. These include the treatment of postmenopausal women with osteoporosis at high risk for fracture and the treatment of osteoporosis in men at high risk for fracture1. DENOZA is also authorized for the remaining indications of the reference biologic, as outlined in the Product Monograph. The product will be available in a prefilled syringe format.
"As a Force for Health, focusing on patient access to appropriate treatment options is a core part of our mission," said Martin Arès, President, Apotex Canada and Rest of World. "Osteoporosis is a significant public health issue, affecting more than 2.3 million Canadians2. The approval of DENOZA reflects our continued commitment to helping improve access to treatment options and contributing to a sustainable healthcare system, while offering healthcare professionals and patients additional choices in care."
Dr. Angela M. Cheung, Professor of Medicine, KY and Betty Ho Chair in Integrative Medicine, University of Toronto, Senior Physician Scientist at University Health Network, and Founding Director of the University Health Network Osteoporosis Program, added: "Timely access to osteoporosis therapies plays an important role in supporting patient care and helping reduce the impact of this underdiagnosed condition. The introduction of additional treatment options, including biosimilars such as DENOZA, can support healthcare providers and patients by broadening available choices within the current treatment landscape."
Dr. Famida Jiwa, President and CEO of Osteoporosis Canada, also welcomed the approval, noting: "Expanding access to therapies is an important step in supporting Canadians living with osteoporosis. The approval of DENOZA adds another option to the range of treatments available within the healthcare system."
Healthcare professionals should refer to the complete Product Monograph for detailed information on warnings, precautions, adverse reactions, and patient monitoring requirements.
About Apotex
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Learn more about us at www.apotex.com.
1 Product Monograph: https://pdf.hres.ca/dpd_pm/00083929.PDF
2 Osteoporosis Canada. Facts and Statistics: https://osteoporosis.ca/facts-and-stats/
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