Amsparity
Authorised
This medicine is authorised for use in the European Union
adalimumab
MedicineHumanAuthorised
Overview
Amsparity 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);
- polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis (both rare diseases causing inflammation in 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;
- 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 (acne inversa), a chronic 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).
Amsparity 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 Amsparity in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Amsparity contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Amsparity is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Amsparity is Humira.
Amsparity is available 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 Amsparity if their doctor considers it appropriate.
Amsparity 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 Amsparity is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
For more information about using Amsparity, see the package leaflet or contact your doctor or pharmacist.
The active substance in Amsparity, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to 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 Amsparity is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Laboratory studies comparing Amsparity with the reference medicine Humira have shown that the active substance in Amsparity is highly similar to that in Humira in terms of structure, purity and biological activity. Studies have also shown that giving Amsparity produces similar levels of the active substance in the body to giving Humira.
In addition, a main study involving 597 patients with moderate to severe active rheumatoid arthritis whose disease had not responded well enough to methotrexate has shown that Amsparity is as effective as Humira in reducing symptoms of the disease. The study compared the two medicines, each given with methotrexate. After 12 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 68% (203 of 297 patients) with Amsparity and 71% (214 of 300 patients) with Humira.
Because Amsparity is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Amsparity.
The safety of Amsparity 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, Amsparity 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 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).
Amsparity 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 Amsparity, see the package leaflet.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Amsparity has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. In addition, a study in rheumatoid arthritis has shown that the effectiveness of Amsparity is equivalent to that of Humira.
All these data were considered sufficient to conclude that Amsparity 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 Amsparity outweigh the identified risks and it can be authorised for use in the EU.
Patients treated with Amsparity must be given a reminder card with information on the safety of the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amsparity have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Amsparity are continuously monitored. Side effects reported with Amsparity are carefully evaluated and any necessary action taken to protect patients.
Amsparity received a marketing authorisation valid throughout the EU on 13 February 2020.
Product information
Latest procedure affecting product information: IAIN/0007
12/12/2023
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).
Product details
- Name of medicine
- Amsparity
- 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
ImmunosuppressantsTherapeutic indication
Rheumatoid arthritis
Amsparity 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.
Amsparity 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
Amsparity 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). Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years.
Enthesitis-related arthritis
Amsparity 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.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Amsparity 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
Amsparity 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 non-steroidal anti-inflammatory drugs (NSAIDs).
Psoriatic arthritis
Amsparity 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 and to improve physical function.
Psoriasis
Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Paediatric plaque psoriasis
Amsparity 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
Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
Crohn’s disease
Amsparity 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
Amsparity 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
Amsparity 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
Amsparity 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.
Adolescent hidradenitis suppurativa
Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
Paediatric uveitis
Amsparity 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.
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