Halimatoz

Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks. The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child’s weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose. After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate.

Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz.

For more information about using Halimatoz, see the package leaflet or contact your doctor or pharmacist.

The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity. Studies have also shown that giving Halimatoz produces similar levels of the active substance in the body to giving Humira.

In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis. The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.

Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.

The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.

Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.

Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient’s own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).

Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).

For the full list of side effects and restrictions with Halimatoz, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.

In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition. All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses. Therefore, the Agency’s view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.

The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine. These packs will include information on the safety of the medicine. An alert card will also be given to patients.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz have also been included in the summary of product characteristics and the package leaflet.

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

Halimatoz received a marketing authorisation valid throughout the EU on 26 July 2018.