What is Abasaglar - insulin glargine and what is it used for?
Abasaglar is a medicine that contains the active substance insulin glargine. It is indicated for the treatment of diabetes in adults and children from two years of age. Abasaglar is a 'biosimilar' medicine. This means that it should have been similar to a biological medicine (the 'reference medicine') that is already authorized in the European Union (EU). The reference medicine for Abasaglar is Lantus. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Abasaglar used - insulin glargine?
Abasaglar is available as cartridges and single-use pre-filled pens (KwikPen) and can only be obtained with a prescription. Abasaglar is given by injection under the skin (under the skin) into the abdominal wall (belly), thigh or deltoid region (shoulder). The injection site should be varied at each injection to avoid skin changes (including thickening) which may reduce the action of insulin compared to expected. Abasaglar is given once a day, at the same time of the day. The dose is adjusted on a case-by-case basis. To find the lowest effective dosage, the patient's blood glucose (sugar) level should be monitored regularly. In patients with type 2 diabetes, Abasaglar can also be given together with antidiabetic medicines taken by mouth.
Abasaglar can be injected by the patient himself, provided he has received appropriate instructions. For further information, see the package leaflet.
How does Abasaglar work - insulin glargine?
Diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood. Abasaglar is a replacement insulin that is very similar to the insulin the body makes. Replacement insulin has the same mechanisms of action as naturally produced insulin and promotes the penetration of glucose into blood cells. By controlling the level of glucose in the blood, it reduces the symptoms and complications of diabetes. The active ingredient in Abasaglar, insulin glargine is produced by a method known as 'recombinant DNA technique': it is made by bacteria that have been given a gene (DNA) that allows them to produce insulin glargine. Insulin glargine is slightly different from human insulin. This difference leads to its slower and more regular absorption by the body after injection, with a long-lasting action.
What benefit has Abasaglar - insulin glargine shown during the studies?
Studies have been carried out to show that the way Abasaglar is absorbed in the body and its mechanism of action on blood glucose are similar to those seen in Lantus. In addition, treatment with Abasaglar once daily was shown to be similar to treatment with the reference medicine, Lantus, in two studies submitted to support the application involving a total of 1,295 adults with diabetes. In both studies, the main measure of effectiveness was the change after 6 months of treatment in the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of blood glucose control.
- In one study, Abasaglar was compared with Lantus as an adjunct to short-acting insulin therapy in 536 patients with type 1 diabetes. In these patients, pre-treatment HbA1c averaged 7. 8% while the decline after 6 months was similar (0.35% in the group treated with Abasaglar and 0.46% in the group treated with Lantus). 34.5% of patients treated with Abasaglar and 32.2% of those treated with Lantus were below the 7% target.
- In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, in addition to antidiabetic medicines taken by mouth. Initial HbA1c averaged 8.3%, a figure which fell below 7% in 48.8% of subjects treated with Abasaglar and in 52.5% of patients treated with Lantus, with a decrease average percentage of 1.29% and 1.34% respectively.
What is the risk associated with Abasaglar - insulin glargine?
The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels). Reactions at the injection site (redness, pain, itching and swelling) and skin reactions (rashes) were seen more often in children than in adults. For the full list of side effects and limitations reported with Abasaglar, see the package leaflet.
Why has Abasaglar - insulin glargine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and efficacy profile to Lantus. Therefore, the CHMP considered that, as in the case of Lantus, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Abasaglar.
What measures are being taken to ensure the safe and effective use of Abasaglar - insulin glargine?
A risk management plan has been developed to ensure that Abasaglar is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Abasaglar, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
More information about Abasaglar - insulin glargine
On 09 September 2014, the European Commission issued a "Marketing Authorization" for Abasria, valid throughout the European Union. The name of the medicine was changed to Abasaglar on 3 December 2014. For more information on Abasaglar therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
The information on Abasaglar - insulin glargine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
