Lusduna

insulin glargine

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This is a summary of the European public assessment report (EPAR) for Lusduna. 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 Lusduna.

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

What is Lusduna and what is it used for?

Lusduna is a medicine used in patients aged at least 2 years for the treatment of diabetes. It contains the active substance insulin glargine.

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

How is Lusduna used?

Lusduna is available in pre-filled disposable pens and can only be obtained with a prescription. It is given by injection under the skin in the belly, the thigh, or the upper arm.

Lusduna is used once a day at the same time each day. The dose of Lusduna is worked out for each patient and depends on the patient’s blood glucose (sugar) level and treatment with other insulin medicines. Lusduna can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.

For further information, see the package leaflet.

How does Lusduna work?

Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes). Lusduna is a replacement insulin that acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.

Insulin glargine, the active substance in Lusduna, enters the bloodstream more slowly than human insulin after injection and so it works for longer.

What benefits of Lusduna have been shown in studies?

Extensive laboratory studies comparing Lusduna with Lantus have shown that insulin glargine in Lusduna is highly similar to that in Lantus in terms of chemical structure, purity and biological activity. Two additional studies showed that Lusduna is absorbed into the body and works on blood glucose in the same way as the reference medicine, Lantus.

Because Lusduna is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.

Two supportive studies found that the effectiveness of once-daily Lusduna was comparable to Lantus. In both studies, the main measure of effectiveness was the change after 24 weeks of treatment in the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled.

In the first supportive study, involving 506 patients with type 1 diabetes, the average HbA1c score was reduced from 8.0 to 7.4% with both Lusduna and Lantus. In the second study, involving 531 patients with type 2 diabetes, the average reduction in HbA1c was from 8.3 to 7.2% with Lusduna and from 8.4 to 7.2% with Lantus.

What are the risks associated with Lusduna?

The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). For the full list of all side effects and restrictions with Lusduna, see the package leaflet.

Why is Lusduna approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna 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 Lusduna be given marketing authorisation.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lusduna have been included in the summary of product characteristics and the package leaflet.

Other information about Lusduna

The European Commission granted a marketing authorisation valid throughout the European Union for Lusduna on 4 January 2017.

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

Name Language First published Last updated
Lusduna : EPAR - Summary for the public BG = bălgarski 2017-01-12  
Lusduna : EPAR - Summary for the public ES = español 2017-01-12  
Lusduna : EPAR - Summary for the public CS = čeština 2017-01-12  
Lusduna : EPAR - Summary for the public DA = dansk 2017-01-12  
Lusduna : EPAR - Summary for the public DE = Deutsch 2017-01-12  
Lusduna : EPAR - Summary for the public ET = eesti keel 2017-01-12  
Lusduna : EPAR - Summary for the public EL = elliniká 2017-01-12  
Lusduna : EPAR - Summary for the public EN = English 2017-01-12  
Lusduna : EPAR - Summary for the public FR = français 2017-01-12  
Lusduna : EPAR - Summary for the public IT = italiano 2017-01-12  
Lusduna : EPAR - Summary for the public LV = latviešu valoda 2017-01-12  
Lusduna : EPAR - Summary for the public LT = lietuvių kalba 2017-01-12  
Lusduna : EPAR - Summary for the public HU = magyar 2017-01-12  
Lusduna : EPAR - Summary for the public MT = Malti 2017-01-12  
Lusduna : EPAR - Summary for the public NL = Nederlands 2017-01-12  
Lusduna : EPAR - Summary for the public PL = polski 2017-01-12  
Lusduna : EPAR - Summary for the public PT = português 2017-01-12  
Lusduna : EPAR - Summary for the public RO = română 2017-01-12  
Lusduna : EPAR - Summary for the public SK = slovenčina 2017-01-12  
Lusduna : EPAR - Summary for the public SL = slovenščina 2017-01-12  
Lusduna : EPAR - Summary for the public FI = suomi 2017-01-12  
Lusduna : EPAR - Summary for the public SV = svenska 2017-01-12  
Lusduna : EPAR - Summary for the public HR = Hrvatski 2017-01-12  

This EPAR was last updated on 12/01/2017 .

Authorisation details

Product details

Product details for Lusduna
NameLusduna
Agency product numberEMEA/H/C/004101
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 Lusduna
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union04/01/2017

Contact address:

Merck Sharp & Dohme Limited
Hertford Road 
Hoddesdon EN11 9BU 
United Kingdom

Product information

Product information

04/01/2017  Lusduna -EMEA/H/C/004101 --

Name Language First published Last updated
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  
Lusduna : EPAR - Product Information HR = Hrvatski 2017-01-12  

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
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  
Lusduna : EPAR - All Authorised presentations HR = Hrvatski 2017-01-12  

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

Initial marketing-authorisation documents

Name Language First published Last updated
Lusduna : EPAR - Public assessment report HR = Hrvatski 2017-01-12  
CHMP summary of positive opinion for Lusduna HR = Hrvatski 2016-11-11  

Authorised

This medicine is approved for use in the European Union

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