Alymsys

Alymsys can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.

Alymsys is given by infusion (drip) into a vein. The first infusion of Alymsys should last 90 minutes, but subsequent infusions may be given more quickly if the earlier infusion has not caused unacceptable side effects. The dose depends on the patient’s weight, the type of cancer being treated and the other cancer medicines being used. Treatment is continued for as long as the patient benefits from it. The doctor may interrupt or stop treatment if the patient develops certain side effects.

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

The active substance in Alymsys, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes new blood vessels grow. By attaching to VEGF, Alymsys stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.

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

In addition, a study involving 627 patients with advanced non-small cell lung cancer showed that Alymsys was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. The cancer responded to treatment in 40% of those given Alymsys and 45% of those given Avastin, which was considered comparable.

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

The safety of Alymsys 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 Avastin.

The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Alymsys, see the package leaflet.

Alymsys must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant (genetically engineered) antibodies. It must not be given to pregnant women.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Alymsys has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, studies in non-small cell lung cancer have shown that the safety and effectiveness of Alymsys is equivalent to that of Avastin in this indication.

All these data were considered sufficient to conclude that Alymsys will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Avastin, the benefits of Alymsys 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 Alymsys have been included in the summary of product characteristics and the package leaflet.

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

Alymsys received a marketing authorisation valid throughout the EU on 26 March 2021.