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Wezlana (ustekinumab)
Sponsor
ARTGs
Device/Product name
Wezlana
Active Ingredient
Ustekinumab
Date of decision
Published
Submission type
New Biosimilar
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 28 February 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 31 October 2023 |
Advisory Committee meeting | 30 November and 1 December 2023 |
Registration decision (Outcome) | 18 January 2024 |
Completion of administrative activities and registration on ARTG | 22 January 2024 |
Number of working days from submission dossier acceptance to registration decision* | 196 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
No
Dose forms
Solution for injection and solution for infusion
Strength
45 mg/0.5 mL, 90 mg/1 mL and 130 mg/26 mL
Containers
Vial and pre-filled syringe
Pack sizes
One
Routes of administration
Subcutaneous and intravenous
Dosage
Plaque psoriasis
Adults
For the treatment of plaque psoriasis, Wezlana is administered by subcutaneous injection. The recommended dose of Wezlana is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg administered over Weeks 0 and 4, then every 12 weeks thereafter may be used in patients with a body weight greater than 100 kg.
Paediatric population, 6 years and older
For the treatment of plaque psoriasis, Wezlana should be administered by subcutaneous injection. The recommended dose of Wezlana is based on body weight (refer to Table 1 of the Product Information). Wezlana should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Psoriatic arthritis
For the treatment of psoriatic arthritis, Wezlana is administered by subcutaneous injection. The recommended dose of Wezlana is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Some patients with a body weight greater than 100 kg received a 90 mg dose in clinical trials and observed a clinical benefit.
Treatment should be discontinued in patients who have shown no response after 28 weeks of treatment.
Crohn’s disease and ulcerative colitis
For the treatment of Crohn’s disease and ulcerative colitis, the recommended treatment regimen is to initiate Wezlana with a single intravenous (IV) tiered dose based on body weight (refer to Table 3 of the Product Information).
After the initial IV dose, Wezlana should then be administered subcutaneously. The first subcutaneous dose of 90 mg Wezlana should be administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
For further information refer to the Product Information.
Pregnancy category
B1
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
All batches of Wezlana (ustekinumab) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
The CPD, as described in "Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines" (ARGPM) should be provided for Wezlana upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.