Overview

Idacio is a medicine that acts on the immune system (the body’s natural defences) and is used to treat the following conditions:

  • plaque psoriasis (a disease causing red, scaly patches on the skin);
  • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
  • rheumatoid arthritis (a disease causing inflammation of the joints);
  • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there are clear signs of inflammation but X-ray does not show disease;
  • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
  • Crohn’s disease (a disease causing inflammation of the gut);
  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • hidradenitis suppurativa (also known as acne inversa, a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin);
  • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

Idacio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Idacio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.

Idacio contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Idacio is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Idacio is Humira. 

Idacio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen, and is usually given every 2 weeks. The dose and frequency of injection depend on the condition to be treated and the dose for a child is usually calculated according to the child’s weight. After training, patients or their carers may inject Idacio if their doctor considers it appropriate.

Idacio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Idacio is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.

For more information about using Idacio, see the package leaflet or contact your doctor or pharmacist.

The active substance in Idacio, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Idacio is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

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

In addition, a study involving 443 patients with plaque psoriasis has shown that Idacio is as effective as Humira in controlling the disease. The study compared injections of the two medicines given under the skin every 2 weeks: after 16 weeks, 90% of those treated with Idacio and 92% of those treated with Humira had at least a 75% reduction in signs and symptoms of psoriasis.

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

The safety of Idacio has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Humira. The most common side effects with adalimumab (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.

Like other medicines of its class, Idacio may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.

Other rare serious side effects of adalimumab (which may affect up to 1 in 1,000 people) include failure of the bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient’s own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).

Idacio must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).

For the full list of side effects and restrictions with Idacio, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Idacio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. In addition, studies in psoriasis have shown that the effectiveness of Idacio is equivalent to that of Humira.

All these data were considered sufficient to conclude that Idacio will behave in the same way as Humira in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Humira, the benefits of Idacio outweigh the identified risks and it can be authorised for use in the EU.

The company that markets Idacio must provide educational packs for doctors who prescribe the medicine. These packs will include information on the safety of the medicine. An alert card will also be given to patients.

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

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

Idacio received a marketing authorisation valid throughout the EU on 2 April 2019.

Idacio : EPAR - Medicine overview

Idacio : EPAR - Risk-management-plan summary

Product information

Idacio : EPAR - Product information

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română (RO) (4.27 MB - PDF)
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Suomi (FI) (4.21 MB - PDF)
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Latest procedure affecting product information: R/0022

30/10/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Idacio : EPAR - All authorised presentations

български (BG) (80.54 KB - PDF)
español (ES) (43.96 KB - PDF)
čeština (CS) (101.21 KB - PDF)
dansk (DA) (12.6 KB - PDF)
Deutsch (DE) (106.53 KB - PDF)
eesti keel (ET) (111.07 KB - PDF)
ελληνικά (EL) (87.47 KB - PDF)
français (FR) (12.62 KB - PDF)
hrvatski (HR) (92.63 KB - PDF)
íslenska (IS) (59.59 KB - PDF)
italiano (IT) (12.43 KB - PDF)
latviešu valoda (LV) (123.07 KB - PDF)
lietuvių kalba (LT) (130.39 KB - PDF)
magyar (HU) (169.2 KB - PDF)
Malti (MT) (171.31 KB - PDF)
Nederlands (NL) (39.58 KB - PDF)
norsk (NO) (47.16 KB - PDF)
polski (PL) (77.43 KB - PDF)
português (PT) (33.55 KB - PDF)
română (RO) (73.86 KB - PDF)
slovenčina (SK) (114.22 KB - PDF)
slovenščina (SL) (146.52 KB - PDF)
Suomi (FI) (13.29 KB - PDF)
svenska (SV) (64.89 KB - PDF)

Product details

Name of medicine
Idacio
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Psoriatic
  • Psoriasis
  • Spondylitis, Ankylosing
  • Uveitis
  • Hidradenitis Suppurativa
  • Colitis, Ulcerative
  • Crohn Disease
  • Arthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Idacio in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Idacio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.

Enthesitis-related arthritis

Idacio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.

Psoriatic arthritis

Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.

Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Psoriasis

Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Paediatric plaque psoriasis

Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

Hidradenitis suppurativa (HS)

Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.

Crohn’s disease

Idacio is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn's disease

Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis

Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Uveitis

Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.

Paediatric Uveitis

Idacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Authorisation details

EMA product number
EMEA/H/C/004475

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder
Fresenius Kabi Deutschland GmbH

Else-Kroner-Strasse 1
61352 Bad Homburg v.d.H.
Germany

Opinion adopted
31/01/2019
Marketing authorisation issued
02/04/2019
Revision
11

Assessment history

Idacio : EPAR - Procedural steps taken and scientific information after authorisation

Idacio : EPAR - Public assessment report

CHMP summary of positive opinion for Idacio

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