Yesintek (ustekinumab)
Yesintek is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults, and plaque psoriasis in children aged 6 years and older. Yesintek contains the active ingredient ustekinumab.
Yesintek is a biosimilar medicine to Stelara. A biosimilar medicine is highly similar to an already approved product with no clinically meaningful differences in safety, effectiveness or quality.
Yesintek is approved to treat:
- adults and children 6 years and older with moderate to severe chronic (does not go away) plaque psoriasis (a skin condition that causes red, scaly patches on the skin)
- adults with active psoriatic arthritis (an inflammatory disease of the joints that is usually accompanied by psoriasis)
- adults with moderately to severely active Crohn’s disease (an inflammatory disease of the bowel)
- adults with moderate to severe ulcerative colitis (an inflammatory disease of the bowel).
The active ingredient in Yesintek is ustekinumab. Ustekinumab is a monoclonal antibody, a medicine that recognises and binds to specific proteins and helps the immune system fight disease.
Ustekinumab blocks the action of 2 proteins in the body called interleukin 12 (IL 12) and interleukin 23 (IL 23). IL 12 and IL 23 are made by the body’s immune system.
In people with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis, IL 12 and IL 23 can cause the immune system to attack healthy parts of the body. Ustekinumab blocks IL 12 and IL 23, helping stop the immune system from attacking the body.
The effectiveness and safety of Yesintek were assessed in one main clinical study and one supporting study.
The main clinical study compared the effectiveness and safety of Yesintek with the already approved reference product, Stelara.
Key findings from clinical studies
- Yesintek was shown to be bioequivalent (works the same way in the body) to the reference product (Stelara).
- No significant differences regarding safety were identified between Yesintek and the reference product (Stelara).
- A higher number of treatment-emergent adverse events (undesirable events not present before treatment, or already present events that get worse following treatment) were reported for Yesintek. These events were primarily related to infections and were mild to moderate in nature and not considered serious.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Yesintek and the medicine can be registered in Australia.
More detailed information on why the TGA approved Yesintek will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and therefore may not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Yesintek can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Yesintek can be accessed through the searchable TGA eBusiness Services or ARTG databases.
- YESINTEK ustekinumab 130 mg/26 mL solution for intravenous infusion injection vial (484546)
- YESINTEK ustekinumab 45 mg/0.5 mL solution for injection pre-filled syringe (484547)
- YESINTEK ustekinumab 45 mg/0.5 mL solution for injection vial (484548)
- YESINTEK ustekinumab 90 mg/1 mL solution for injection pre-filled syringe (484549)
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.