What is Abasaglar and what is it used for - insulin glargine?
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 has already been 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 disposable pre-filled cartridges and pens (KwikPen) and can only be obtained with a prescription. Abasaglar is given by subcutaneous injection (under the skin) into the abdominal wall (belly), thigh or deltoid region (shoulder). At each injection it is advisable to vary the site of inoculation to avoid skin changes (including thickening) that can reduce the action of insulin compared to forecasts. Abasaglar is given once a day, at the same time. The dose is adjusted on a case by case basis. To find the minimum effective dosage the level of glucose (sugar) in the patient's blood must be regularly monitored. In patients with type 2 diabetes, Abasaglar can also be given together with antidiabetic medicines taken by mouth.
The injection of Abasaglar can be carried out by the patient himself, provided he has received appropriate instructions. For more information, see the package leaflet.
How does Abasaglar - insulin glargine work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. Abasaglar is a replacement insulin very similar to the insulin produced by the body. 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 of Abasaglar, insulin glargine, is produced by a method known as "recombinant DNA technique": it is obtained from bacteria in which a gene (DNA) has been inserted that allows them to produce insulin glargine. Insulin glargine is slightly different from human insulin. This difference involves a slower and more regular absorption by the body after the injection, with a long lasting action.
What benefit has Abasaglar shown - insulin glargine during the studies?
Studies have been conducted to show that the way Abasaglar is absorbed into the body and its mechanism of action on blood glucose are similar to those seen in Lantus. Furthermore, treatment with Abasaglar once a day was shown to be similar to treatment with the reference medicine, Lantus, in two studies presented in support of the authorization request, conducted on a total of 1 295 adults with diabetes. In both studies the main measure of effectiveness was the change after 6 months in the treatment of the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the efficacy of blood glucose control.
- In one study, Abasaglar was compared with Lantus in addition to a short-acting insulin therapy in 536 patients with type 1 diabetes. In these patients before treatment HbA1c was on average equal to 7, 8% while the decrease 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. The initial HbA1c was on average 8.3%, a figure that fell below 7% in 48.8% of subjects treated with Abasaglar and in 52.5% of patients treated with Lantus, with a drop average percentage of 1.29% and 1.34% respectively.
What is the risk associated with Abasaglar - insulin glargine?
The most common side effect of Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels). Injection site reactions (redness, pain, itching and swelling) and skin reactions (eruptions) have been observed more often in children than in adults. For the full list of all side effects and restrictions with Abasaglar, see the package leaflet.
Why has Abasaglar - insulin glargine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has 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 a 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 included in the summary of product characteristics and the package leaflet for Abasaglar, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Further information on Abasaglar - insulin glargine
On 9 September 2014, the European Commission issued a marketing authorization for Abasria, valid throughout the European Union. On 3 December 2014 the name of the medicine was changed to Abasaglar. For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
