Zessly

infliximab

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About

An overview of Zessly and why it is authorised in the EU

Zessly is an anti-inflammatory medicine for treating the following diseases:

  • rheumatoid arthritis (disease causing inflammation of the joints)
  • Crohn’s disease (disease causing inflammation of the gut)
  • ulcerative colitis (inflammation and ulcers in the lining of the gut)
  • ankylosing spondylitis (inflammation of spine causing back pain)
  • psoriasis (red, scaly patches on the skin)
  • psoriatic arthritis (psoriasis with inflammation of the joints).

Zessly is used mainly in adults, usually when other medicines or treatments have failed or cannot be used. For Crohn’s disease and ulcerative colitis, it is also used in children from 6 years of age. For some conditions, Zessly is also used in combination with another medicine, methotrexate.

Zessly is a ‘biosimilar medicine’. This means that it is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zessly is Remicade.

Zessly contains the active substance infliximab.

How is Zessly used?

Zessly is given as an infusion (drip) into a vein over 2 hours. After each infusion, the patient should be monitored for 1 to 2 hours in case they have an allergic reaction, such as swelling of the mouth, face and throat, skin rash, and difficulty breathing.

To reduce the risk of infusion reactions, patients may be given other medicines before or during treatment with Zessly or the infusion may be slowed down.

The dose of Zessly and how often it is given depends on the patient’s body weight and the condition being treated. After the initial doses, it is usually given once every 8 weeks. For more information about using Zessly, see the package leaflet or contact your doctor or pharmacist.

Zessly can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Zessly is used to treat.

How does Zessly work?

The active substance in Zessly, infliximab, is a monoclonal antibody (a type of protein) that attaches to a substance in the body called tumour necrosis factor alpha (TNF-α). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Zessly is used to treat. By attaching to TNF-α, infliximab blocks its activity and thereby reduces inflammation and other symptoms of the diseases.

What benefits of Zessly have been shown in studies?

Laboratory studies comparing Zessly with Remicade have shown that the active substance in Zessly is highly similar to that in Remicade in terms of structure, purity and biological activity. Studies have also shown that giving Zessly produces similar levels of the active substance in the body to giving Remicade.

In addition, Zessly was as effective as Remicade in a study of 650 rheumatoid arthritis patients whose previous treatment with methotrexate alone had not worked well enough. The study looked at the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 14 weeks of treatment. A similar proportion of patients achieved a 20% reduction with the two medicines (around 61.1% with Zessly and 63.5% with Remicade).

Because Zessly is a biosimilar medicine, the studies on effectiveness and safety carried out with Remicade do not all need to be repeated for Zessly.

What are the risks associated with Zessly?

The most common side effects with Zessly (seen in more than 1 patient in 10) are viral infections (such as flu and cold sores), headache, upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. For the full list of side effects of Zessly, see the package leaflet.

Zessly must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Zessly. Zessly must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Why is Zessly authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zessly has been shown overall to have a comparable quality, safety and effectiveness to Remicade. Therefore, the Agency’s view was that, as for Remicade, the benefit of Zessly outweighs the identified risk and it can be authorised.

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

The company that markets Zessly will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine. In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn’s disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.

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

As for all medicines, data on the use of Zessly are continuously monitored. Side effects reported with Zessly are carefully evaluated and any necessary action taken to protect patients.

Other information about Zessly

Zessly received a marketing authorisation valid throughout the EU on 18 May 2018.

Name Language First published Last updated
Zessly : EPAR - Summary for the public BG = bălgarski 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public ES = español 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public CS = čeština 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public DE = Deutsch 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public ET = eesti keel 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public EL = elliniká 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public EN = English 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public FR = français 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public IT = italiano 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public LV = latviešu valoda 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public LT = lietuvių kalba 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public HU = magyar 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public MT = Malti 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public NL = Nederlands 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public PL = polski 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public PT = português 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public RO = română 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public SK = slovenčina 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public SL = slovenščina 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public FI = suomi 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public SV = svenska 2018-05-30 2018-06-01
Zessly : EPAR - Summary for the public HR = Hrvatski 2018-05-30 2018-06-01

This EPAR was last updated on 30/05/2018 .

Authorisation details

Product details

Product details for Zessly
NameZessly
Agency product numberEMEA/H/C/004647
Active substance

infliximab

International non-proprietary name (INN) or common name

infliximab

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidColitis, UlcerativeArthritis, PsoriaticCrohn DiseasePsoriasis
Anatomical therapeutic chemical (ATC) code L04AB02
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 Zessly
Marketing-authorisation holder

Sandoz GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/05/2018

Contact address:

Sandoz GmbH
Biochemiestrasse 10 
6250 Kundl 
Austria

Product information

Product information

18/05/2018  Zessly -EMEA/H/C/004647 --

Name Language First published Last updated
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  
Zessly : EPAR - Product Information HR = Hrvatski 2018-05-30  

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
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  
Zessly : EPAR - All Authorised presentations HR = Hrvatski 2018-05-30  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. For more information see section 5.1

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Zessly : EPAR - Public assessment report HR = Hrvatski 2018-05-30  
CHMP summary of positive opinion for Zessly HR = Hrvatski 2018-03-23  

Authorised

This medicine is approved for use in the European Union