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Steqeyma (Ustekinumab)
ARTGs
Device/Product name
Steqeyma
Active Ingredient
Ustekinumab
Date of decision
Published
Submission type
New chemical entity - Type A application
ATC codes
L04AC05
Decision
Approved for entry in the Australian Register of Therapeutic Goods (ARTG)
What was the decision based on
The decision to approve steqeyma was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The benefit-risk profile of Steqeyma was considered favourable for the approved therapeutic uses.
The benefit-risk profile of Steqeyma was considered favourable for the approved therapeutic uses.
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 | 3 October 2023 |
| Evaluation completed | 12 June 2024 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee on Medicines (ACM) advice | 16 August 2024 |
| Registration decision (Outcome) | 2 September 2024 |
| Completion of administrative activities and registration in ARTG | 11 September 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 209 days |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Injection, concentrated
Strength
For subcutaneous administration:
Steqeyma 45 mg solution for injection in pre-filled syringe.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Steqeyma 90 mg solution for injection in pre-filled syringe.
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
For intravenous (IV) infusion only:
Steqeyma 130 mg concentrate for solution for infusion.
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Steqeyma 45 mg solution for injection in pre-filled syringe.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Steqeyma 90 mg solution for injection in pre-filled syringe.
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
For intravenous (IV) infusion only:
Steqeyma 130 mg concentrate for solution for infusion.
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Other ingredients
disodium edetate
histidine hydrochloride monohydrate
histidine
methionine
polysorbate 80
sucrose
water for injections
Containers
Vial Glass Type I Clear
Pack sizes
1 pre-filled syringe (45 mg) and 1 pre-filled syringe (90 mg)
Routes of administration
Steqeyma is for subcutaneous injection and intravenous (IV) infusion.
Dosage
The route of administration and dose depends on the condition being treated and patient’s body weight.
For dosage information refer to the Product Information (PI).
Use the TGA PI/CMI search facility to view the current PI and Consumer Medicines Information.
Pregnancy category
Category B1.
It is not known whether ustekinumab can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Ustekinumab should be given to a pregnant woman only if the benefit clearly outweighs the risk. Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Developmental toxicity studies of ustekinumab were conducted in cynomolgus monkeys. No evidence of maternal toxicity, embryotoxicity or teratogenicity was observed at doses up to 45 mg/kg following weekly or twice weekly administration via the IV or SC routes, respectively, during the period of organogenesis. However, animal reproductive and developmental studies are not always predictive of human response.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This 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 and Prescribing medicines in pregnancy database.
It is not known whether ustekinumab can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Ustekinumab should be given to a pregnant woman only if the benefit clearly outweighs the risk. Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Developmental toxicity studies of ustekinumab were conducted in cynomolgus monkeys. No evidence of maternal toxicity, embryotoxicity or teratogenicity was observed at doses up to 45 mg/kg following weekly or twice weekly administration via the IV or SC routes, respectively, during the period of organogenesis. However, animal reproductive and developmental studies are not always predictive of human response.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This 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 and Prescribing medicines in pregnancy database.
What was approved
Steqeyma (ustekinumab) was approved for the following therapeutic uses.
Plaque Psoriasis
Adults - Steqeyma 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 - Steqeyma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age (60kg and over) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA)
Steqeyma, 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
Steqeyma 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
Steqeyma is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
What is this medicine and how does it work
Steqeyma is a biological medicine used to treat several inflammatory conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease. Steqeyma belongs to a group of medicines called immunosuppressants, which work by weakening part of the immune system.
Steqeyma (ustekinumab) is a biosimilar medicine to Stelara® (ustekinumab). Ustekinumab, the active substance in Steqeyma, is a human monoclonal antibody. It targets and binds to two specific proteins in the immune system: interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins play a crucial role in the inflammatory process.
Steqeyma (ustekinumab) is a biosimilar medicine to Stelara® (ustekinumab). Ustekinumab, the active substance in Steqeyma, is a human monoclonal antibody. It targets and binds to two specific proteins in the immune system: interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins play a crucial role in the inflammatory process.
What post-market commitments will the sponsor undertake
Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Steqeyma 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 http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided 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.