Health Canada has approved several new biosimilars referencing Amgen’s Prolia/Xgeva (denosumab) and Janssen’s Stelara (ustekinumab) in the first half of 2026, significantly expanding treatment options for osteoporosis, cancer-related bone conditions, and inflammatory diseases in Canada.
Ustekinumab: Imuldosa
Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026, as a biosimilar to Stelara (Janssen) for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Developed by Dong-A ST, it is commercialized globally by Intas Pharmaceuticals through its affiliate Accord Healthcare.
Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody [1], is already approved in Europe (12 December 2024) and in the US as Imuldosa (ustekinumab-srlf; 10 October 2024).
Denosumab: Bildyos and Tuzemty
On 24 March 2026, Henlius and Organon received Canadian approval for Bildyos (denosumab injection, 60 mg/mL) and Tuzemty (denosumab injection, 120 mg/1.7 mL), biosimilars to Prolia and Xgeva, respectively. Denosumab, an anti-RANKL antibody, inhibits osteoclast-mediated bone resorption [2].
Bildyos is indicated for osteoporosis in postmenopausal women and men, glucocorticoid-induced osteoporosis, and bone loss associated with androgen deprivation or aromatase inhibitor therapy. Tuzemty is approved for preventing skeletal-related events in patients with bone metastases from various cancers, as well as giant cell tumour of bone and refractory hypercalcemia of malignancy.
Organon holds exclusive commercialization rights outside China. The FDA approved Bildyos (Prolia reference) and Bilprevda (Xgeva reference), both denosumab-nxxp, on 29 August 2025; Europe approved both on 17 September 2025. Canadian launch followed in June 2026. Approval was based on analytical, non-clinical and clinical data showing no clinically meaningful differences in safety, purity or potency.
Additional Canadian denosumab approvals
Apotex’s Denoza (denosumab injection, 60 mg/mL, Prolia reference) was approved for osteoporosis indications in early April 2026.
On 3 April 2026, Biocon secured Canadian approval for Bosaya (60 mg/mL prefilled syringe) and Vevzuo (120 mg/1.7 mL single-dose vial), biosimilars to Prolia and Xgeva, respectively. All approvals were based on comprehensive analytical, nonclinical, and clinical data demonstrating no clinically meaningful differences in safety, purity, and potency compared with the reference products.
Outside Canada, Biocon’s Vevzuo (Xgeva) and Evfraxy (Prolia) were approved in Europe on 25 and 30 June 2025, while the FDA approved Aukelso (Xgeva; 16 September 2025) and Bosaya (Prolia; 19 December 2025), both denosumab-kyqq.
Global and market context
Market context is increasingly competitive. These denosumab biosimilars join Sandoz’s Wyost and Jubbonti, the first denosumab biosimilars approved in Canada (February and March 2024) [3].
As of September 2026, Europe has approved 14 ustekinumab and 15 denosumab biosimilars, while the US has approved 8 ustekinumab and 19 denosumab biosimilars. In Canada, ustekinumab competition includes Jamteki, Otulfi, Steqeyma, Wezlana, and Imuldosa. This is expected to drive price reductions and improve patient access. Health Canada does not designate biosimilars as interchangeable; interchangeability and substitution decisions are made at the provincial and territorial level.
Related article
Canada eliminates phase III trial requirement for biosimilar approvals
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
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