EMA Authorises Ablymico, a Synthetic Liraglutide for Weight Management

The European Medicines Agency (EMA) has authorised Ablymico (liraglutide), a medicine for weight management. The Ablymico liraglutide weight management authorisation is valid throughout the EU from 15 July 2026. Ablymico is a hybrid medicine, which means it is similar to a reference medicine, Saxenda, but the active substance is made differently. Saxenda’s liraglutide is produced using living cells, while Ablymico’s is made through chemical processes.

Ablymico is used along with diet and increased physical activity to help manage weight in several groups:

Ablymico liraglutide weight management: who it is for

• Adults with obesity, meaning a body mass index (BMI) of 30 or more;
• Adults with overweight, meaning a BMI between 27 and 30, who also have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea;
• Adolescents from 12 years of age with obesity who weigh more than 60 kg; and
• Children from 6 to less than 12 years of age with obesity (a BMI at or above the 95th percentile) who weigh at least 45 kg.

BMI is a measure of a person’s weight in relation to their height. A BMI at the 95th percentile means it is higher than that of 95% of people of the same age and gender. Ablymico can only be obtained with a prescription, and in children from 6 to less than 12 years of age, treatment should be started by a doctor experienced in treating children with obesity.

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How Ablymico is given

Ablymico is injected under the skin once a day using a pre-filled pen, into the thigh, upper arm or belly. The dose is increased slowly over four weeks. Treatment should be stopped if a patient has not lost at least 4% of their initial body weight (for adolescents and children from 6 years of age) or 5% (for adults) after 12 weeks of treatment at the maximum dose or the maximum tolerated dose. The doctor should reassess the need to continue treatment once a year.

How Ablymico works

Liraglutide, the active substance in Ablymico, is a glucagon-like peptide-1 (GLP-1) receptor agonist. It acts in the same way as GLP-1, a natural hormone that regulates appetite. By attaching to receptors for GLP-1 in brain cells, liraglutide produces a feeling of fullness and reduces hunger and food cravings, which helps a person reduce their food intake.

The evidence behind the approval

Studies on the benefits and risks of the active substance in the authorised uses were already carried out with the reference medicine, Saxenda, and did not need to be repeated for Ablymico. The company provided studies on the quality of Ablymico and a study showing that it is bioequivalent to Saxenda. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Side effects and safety

The most common side effects with Ablymico, which may affect more than 1 in 10 people, are nausea, vomiting, diarrhoea and constipation. The full list of side effects and restrictions is in the package leaflet.

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

Why Ablymico was authorised

The EMA concluded that, in line with EU requirements, Ablymico has comparable quality to Saxenda and is bioequivalent to it. On that basis, and as for Saxenda, the Agency decided that the benefits of Ablymico outweigh the identified risks, and it can be authorised for use in the EU. Recommendations and precautions for healthcare professionals and patients have been included in the summary of product characteristics and the package leaflet.

For information about the availability of Ablymico in a specific country, contact the relevant national competent authority.