Abasaglar (previously Abasria)

insulin glargine

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This is a summary of the European public assessment report (EPAR) for Abasaglar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Abasaglar.

For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist.

What is Abasaglar and what is it used for?

Abasaglar is a medicine that contains the active substance insulin glargine. It is used in adults and children over the age of two for the treatment of diabetes.

Abasaglar is a ‘biosimilar medicine’. This means that Abasaglar is similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Abasaglar is Lantus.

How is Abasaglar used?

Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained with a prescription. It is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (upper arm). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.

Abasaglar is given once a day at the same time each day. The dose is adjusted individually, and the patient’s blood glucose (sugar) should be regularly tested to find the lowest effective dose. Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes.

Patients can inject themselves with Abasaglar if they have been trained appropriately.

For further information, see the package leaflet.

How does Abasaglar work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Abasaglar is a replacement insulin that is very similar to the insulin made by the body. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant DNA technology’: it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce insulin glargine.

Insulin glargine is slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.

What benefits of Abasaglar have been shown in studies?

Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts on blood glucose were similar toLantus. In addition, treatment with once-daily Abasaglar has been shown to be comparable to the reference medicine, Lantus, in two supportive studies 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 level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

  • In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes. Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target of 7%.

In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, as an addition to diabetes medicines taken by mouth. Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively.

What are the risks associated with Abasaglar?

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 effectiveness to Lantus. Therefore, the CHMP’s view was that, as for Lantus, the benefit outweighs the identified risk. The Committee recommended that Abasaglar be given marketing authorisation.

Why is Abasaglar 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 effectiveness to Lantus. Therefore, the CHMP’s view was that, as for Lantus, the benefit outweighs the identified risk. The Committee recommended that Abasaglar be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Abasaglar?

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 can be found in the summary of the risk management plan.

Other information about Abasaglar

The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014. The name of the medicine was changed to Abasaglar on 3 December 2014.

For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Abasaglar (previously Abasria) : EPAR - Summary for the public BG = bălgarski 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public ES = español 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public CS = čeština 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public DA = dansk 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public DE = Deutsch 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public ET = eesti keel 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public EL = elliniká 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public EN = English 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public FR = français 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public IT = italiano 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public LV = latviešu valoda 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public LT = lietuvių kalba 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public HU = magyar 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public MT = Malti 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public NL = Nederlands 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public PL = polski 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public PT = português 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public RO = română 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public SK = slovenčina 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public SL = slovenščina 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public FI = suomi 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public SV = svenska 14/10/2014 20/01/2015
Abasaglar (previously Abasria) : EPAR - Summary for the public HR = Hrvatski 14/10/2014 20/01/2015
Name Language First published Last updated
Abasaglar (previously Abasria) : EPAR - Risk-management-plan summary (English only) 14/10/2014 20/01/2015

This EPAR was last updated on 14/07/2015 .

Authorisation details

Product details

Product details for Abasaglar (previously Abasria)
NameAbasaglar (previously Abasria)
Agency product numberEMEA/H/C/002835
Active substance

insulin glargine

International non-proprietary name (INN) or common name

insulin glargine

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AE04
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Abasaglar (previously Abasria)
Marketing-authorisation holder

Eli Lilly Regional Operations GmbH

Revision3
Date of issue of marketing authorisation valid throughout the European Union09/09/2014

Contact address:

Eli Lilly Regional Operations GmbH
Kölblgasse 8-10
1030 Vienna
Austria

Product information

Product information

21/05/2015  Abasaglar (previously Abasria) -EMEA/H/C/002835 -II/0003/G

Name Language First published Last updated
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - Product Information EN = English 14/10/2014 14/07/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015
Abasaglar (previously Abasria) : EPAR - All Authorised presentations EN = English 14/10/2014 14/07/2015

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Abasaglar (previously Abasria) : EPAR - Procedural steps taken and scientific information after authorisation EN = English 20/01/2015 14/07/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Abasria : EPAR - Public assessment report EN = English 14/10/2014  
CHMP summary of positive opinion for Abasria EN = English 27/06/2014  

Authorised

This medicine is approved for use in the European Union

More information on Abasria