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Wezlana (ustekinumab)
Published
Product name
Wezlana
Active ingredient
Ustekinumab
Submission type
New Biosimilar
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Wezlana (ustekinumab) was approved for the following therapeutic use:
Plaque Psoriasis
Adults
Wezlana is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Paediatric population, 6 years and older
Wezlana is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA)
Wezlana, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate.
Crohn’s Disease
Wezlana is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Ulcerative Colitis
Wezlana is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
How this medicine works
Wezlana is a biosimilar medicine to Stelara (ustekinumab). Ustekinumab is an antibody that specifically inhibits the bioactivity of two substances (cytokines) made by immune cells, interleukin 12 (IL-12) and interleukin 23 (IL-23). Levels of IL-12 and IL-23 are elevated in the skin and blood of patients with psoriasis and serum IL-12/23 distinguishes patients with psoriatic arthritis from healthy individuals, implicating IL-12 and IL-23 in the pathophysiology of psoriatic inflammatory diseases. IL-12 and IL-23 are also highly expressed in psoriatic skin. There is evidence implicating IL-23 in bone erosion and destruction. In patients with Crohn’s disease, IL-12 and IL-23 are elevated in the intestines and lymph nodes and both IL-12 and IL-23 can stimulate chronic intestinal inflammation and epithelial cell injury. Wezlana likely exerts its therapeutic effects in psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis by inhibiting IL-12 and IL-23 and thereby alleviating inflammation caused by these cytokines.
Why the TGA approved or did not approve this medicine
Wezlana is a biosimilar to Stelara. Two clinical studies were conducted to confirm biosimilarity of Wezlana to Stelara: a randomised, double-blind, 3-arm, parallel-group, single-dose pharmacokinetic similarity study in healthy adult subjects and a randomised, double-blind, active controlled comparative clinical study in adult subjects with moderate to severe plaque psoriasis. Collectively, these studies established structural and functional similarity and confirmed no clinically meaningful differences between Wezlana and Stelara, thus supporting approval for all indications approved for Stelara for which registration was sought.
Sponsor
ARTG details
- WEZLANA ustekinumab 5 mg / 1.0 mL (130 mg/26 mL) solution for intravenous infusion injection vial (403014)
- WEZLANA ustekinumab 45 mg / 0.5 mL solution for subcutaneous injection vial (403012)
- WEZLANA ustekinumab 45 mg / 0.5 mL solution for subcutaneous injection pre-filled syringe (403013)
- WEZLANA ustekinumab 90 mg/1.0 ml solution for subcutaneous injection pre-filled syringe (403011)