Imuldosa

Imuldosa can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Imuldosa is used for.

In plaque psoriasis and psoriatic arthritis, Imuldosa 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, treatment is started with Imuldosa infusion (drip) into a vein over at least 1 hour. Eight weeks after the first infusion, Imuldosa is injected under the skin. Patients then continue with Imuldosa injected under the skin every 8 or 12 weeks depending on how well the treatment is working.

Patients or their caregivers may inject Imuldosa under the skin once they have been trained, if their doctor thinks that this is appropriate. For more information about using Imuldosa, see the package leaflet or contact your doctor or pharmacist.

The active substance in Imuldosa, 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 Imuldosa with Stelara have shown that the active substance in Imuldosa is highly similar to that in Stelara in terms of structure, purity and biological activity. Studies have also shown that giving Imuldosa produces similar levels of the active substance in the body to giving Stelara.

In addition, a study of 523 patients with moderate to severe plaque psoriasis showed that Imuldosa  was as effective as Stelara in improving symptoms. The improvement in symptoms scores after 8 weeks was similar with both medicines.

Because Imuldosa is a biosimilar medicine, the studies on effectiveness of ustekinumab carried out with Stelara do not all need to be repeated for Imuldosa.

The safety of Imuldosa 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 Imuldosa, 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 reported with ustekinumab include serious hypersensitivity (allergic reaction) including anaphylaxis (sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness).

Imuldosa 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, Imuldosa 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 Imuldosa and Stelara are equivalent in terms of safety and effectiveness in this condition.

All these data were considered sufficient to conclude that Imuldosa will have the same effects as Stelara in its authorised uses. Therefore, the Agency’s view was that, as for Stelara, the benefits of Imuldosa 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 Imuldosa have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Imuldosa are continuously monitored. Suspected side effects reported with Imuldosa are carefully evaluated and any necessary action taken to protect patients.

Imuldosa received a marketing authorisation valid throughout the EU on 12 December 2024.