Canada Approves Multiple Denosumab and Ustekinumab Biosimilars as Global Competition Intensifies
核心洞察
Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease (搜索), ulcerative colitis (搜索), plaque psoriasis (搜索) and psoriatic arthritis (搜索).
Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos (搜索) and Tuzemty (搜索), denosumab biosimilars referencing Prolia and Xgeva respectively.
Apotex (搜索)'s Denoza (搜索) and Biocon's Bosaya (搜索) and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field.
Health Canada has authorized a wave of denosumab and ustekinumab biosimilars across early 2026, adding new competitive pressure to two high-value biologic franchises and setting the stage for price reductions and expanded patient access in Canada.
Imuldosa Becomes Latest Ustekinumab Biosimilar in Canada
Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a biosimilar to Stelara (Janssen) for Crohn's disease (搜索), ulcerative colitis (搜索), plaque psoriasis (搜索) and psoriatic arthritis (搜索). The product was developed by Dong-A ST (搜索) and is commercialized globally by Intas Pharmaceuticals through its affiliate Accord Healthcare.
Ustekinumab is an anti-IL-12/23 p40 (搜索) monoclonal antibody. Imuldosa was already approved in Europe on 12 December 2024 and in the US as Imuldosa (ustekinumab-srlf) on 10 October 2024.
In Canada, ustekinumab competition now includes Jamteki, Otulfi, Steqeyma, Wezlana and Imuldosa.
Henlius and Organon Secure Bildyos and Tuzemty Approvals
On 24 March 2026, Henlius and Organon received Canadian approval for Bildyos (搜索) (denosumab injection, 60 mg/mL) and Tuzemty (搜索) (denosumab injection, 120 mg/1.7 mL), biosimilars to Prolia and Xgeva, respectively. Denosumab is an anti-RANKL (搜索) antibody that inhibits osteoclast-mediated bone resorption.
Bildyos (搜索) is indicated for osteoporosis (搜索) in postmenopausal women and men, glucocorticoid-induced osteoporosis, and bone loss associated with androgen deprivation or aromatase inhibitor therapy. Tuzemty (搜索) is approved for preventing skeletal-related events in patients with bone metastases from various cancers, as well as giant cell tumour of bone (搜索) and refractory hypercalcemia of malignancy (搜索).
Organon holds exclusive commercialization rights outside China. The FDA approved Bildyos (搜索) (Prolia reference) and Bilprevda (Xgeva reference), both denosumab-nxxp, on 29 August 2025, with European approval for both following 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 Denosumab Entrants From Apotex and Biocon
Apotex (搜索)'s Denoza (搜索) (denosumab injection, 60 mg/mL, Prolia reference) was approved for osteoporosis (搜索) indications in early April 2026.
On 3 April 2026, Biocon secured Canadian approval for Bosaya (搜索) (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 (搜索) (Prolia; 19 December 2025), both denosumab-kyqq.
A Crowded Global Biosimilar Landscape
The new Canadian approvals join Sandoz's Wyost and Jubbonti, the first denosumab biosimilars approved in Canada in February and March 2024.
As of September 2026, Europe has approved 14 ustekinumab and 15 denosumab biosimilars, while the US has approved 8 ustekinumab and 19 denosumab biosimilars. The expanding field 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.