Yesintek
Authorised
This medicine is authorised for use in the European Union
ustekinumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Yesintek is a medicine used to treat:
- moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children from 6 years of age whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;
- active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Yesintek may be used alone or combined with methotrexate (a DMARD);
- moderately to severely active Crohn’s disease (inflammation of the gut that causes disease) in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments.
Yesintek contains the active substance ustekinumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Yesintek is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Yesintek is Stelara. For more information on biosimilar medicines, see here.
Yesintek can only be obtained with a prescription and should be given under the supervision of a doctor experienced in diagnosing and treating the diseases that Yesintek is used for.
In plaque psoriasis and psoriatic arthritis, Yesintek is injected under the skin. The first injection is followed by a further injection 4 weeks later, and then an injection every 12 weeks.
In Crohn’s disease, Yesintek treatment is started with an infusion (drip) into a vein over at least 1 hour. Eight weeks after the infusion, treatment with Yesintek is continued as an injection under the skin. Patients then continue with Yesintek injections every 8 or 12 weeks, depending on how well the treatment is working.
If the doctor thinks it is appropriate, patients or their caregivers may inject Yesintek themselves once they have been trained.
For more information about using Yesintek, see the package leaflet or contact your doctor or pharmacist.
The active substance in Yesintek, ustekinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target in the body. Ustekinumab attaches to 2 messenger molecules in the immune system called interleukin 12 and interleukin 23. Both are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn’s disease. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Laboratory studies comparing Yesintek with the reference medicine Stelara have shown that the active substance in Yesintek is highly similar to that in Stelara in terms of structure, purity and biological activity. Studies have also shown that giving Yesintek produces similar levels of the active substance in the body to those seen with Stelara.
In addition, a study of 384 adults with moderate to severe plaque psoriasis showed that Yesintek was as effective as Stelara at improving symptoms of the disease. The improvement in symptoms scores after 12 weeks was similar with both medicines.
Because Yesintek is a biosimilar medicine, the studies on effectiveness of ustekinumab carried out with Stelara do not all need to be repeated for Yesintek.
The safety of Yesintek has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Stelara.
For the complete list of side effects and restrictions of Yesintek, see the package leaflet.
The most common side effects with ustekinumab (seen in more than 1 in 20) include headache and nasopharyngitis (inflammation of the nose and throat). The most serious side effect with ustekinumab (which may affect up to 1 in 1,000 people) is serious hypersensitivity (allergic reaction), including anaphylaxis (sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness).
Yesintek must not be used in patients who have an active infection that the doctor considers important.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Yesintek has a highly similar structure, purity and biological activity to Stelara and is distributed in the body in the same way. In addition, a study in patients with plaque psoriasis has shown that Yesintek and Stelara are equivalent in terms of safety and effectiveness in this condition.
All these data were considered sufficient to conclude that Yesintek will have the same effects as Stelara in its authorised uses. Therefore, the Agency’s view was that, as for Stelara, the benefits of Yesintek outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yesintek have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Yesintek are continuously monitored. Suspected side effects reported with Yesintek are carefully evaluated and any necessary action taken to protect patients.
Yesintek received a marketing authorisation valid throughout the EU on 14 February 2025.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Yesintek
- Active substance
- ustekinumab
- International non-proprietary name (INN) or common name
- ustekinumab
- Therapeutic area (MeSH)
- Psoriasis
- Arthritis, Psoriatic
- Crohn Disease
- Anatomical therapeutic chemical (ATC) code
- L04AC05
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Crohn’s Disease
Yesintek is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with lost response to, or were intolerant to either conventional therapy or a TNFα (tumor necrosis factor alpha) antagonist or have medical contraindications to such therapies.
News on Yesintek
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