Hukyndra

Authorised

This medicine is authorised for use in the European Union

adalimumab

Overview

Hukyndra 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).

Hukyndra 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 Hukyndra in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.

Hukyndra is a ‘biosimilar medicine’. This means that Hukyndra is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Hukyndra is Humira. For more information on biosimilar medicines, see here.

Hukyndra contains the active substance adalimumab.

 

How is Hukyndra used?

Hukyndra is available for injection under the skin in a 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; because Hukyndra is only available in doses of 40 or 80 mg, it is not suitable for children who need less than a 40-mg dose. After training, patients or their carers may inject Hukyndra if their doctor considers it appropriate.

Hukyndra 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 Hukyndra is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.

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

How does Hukyndra work?

The active substance in Hukyndra, 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 Hukyndra is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

What benefits of Hukyndra have been shown in studies?

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

In addition, a study involving 412 adult patients with plaque psoriasis has shown that Hukyndra was as effective as Humira in controlling the disease; average scores measuring the extent and severity of the condition improved by 91% after 16 weeks of treatment with either medicine.

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

What are the risks associated with Hukyndra?

The safety of Hukyndra 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, Hukyndra 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).

Hukyndra 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 Hukyndra, see the package leaflet.

Why is Hukyndra authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hukyndra 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 adults with plaque psoriasis have shown that the safety and effectiveness of Hukyndra is equivalent to that of Humira in this group.

All these data were considered sufficient to conclude that Hukyndra 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 Hukyndra outweigh the identified risks and it can be authorised for use in the EU.

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

Patients treated with Hukyndra 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 Hukyndra have also been included in the summary of product characteristics and the package leaflet.

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

Other information about Hukyndra

Hukyndra received a marketing authorisation valid throughout the EU on 15 November 2021.

Hukyndra : EPAR - Medicine overview

Reference Number: EMA/544649/2021

Hukyndra : EPAR - Risk management plan

Product information

Hukyndra : EPAR - Product information

Hukyndra : EPAR - All authorised presentations

Product details

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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis Hukyndra 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 (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hukyndra 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 Hukyndra 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 DMARD. Hukyndra 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 Hukyndra 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) Hukyndra is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hukyndra 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 (NSAIDs). Psoriatic arthritis Hukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD 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 Hukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hukyndra 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) Hukyndra is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Hukyndra 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 Hukyndra 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 Hukyndra 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. Paediatric ulcerative colitis Hukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hukyndra 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 Hukyndra 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/005548
• Additional monitoring:

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

• 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:
  Stada Arzneimittel AG

  Stadastrasse 2-18; D-61118 Bad Vilbel; Germany

• Opinion adopted:
  16/09/2021
• Marketing authorisation issued:
  15/11/2021
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Hukyndra : EPAR - Public assessment report

AdoptedReference Number: EMA/555939/2021

CHMP summary of positive opinion for Hukyndra

AdoptedReference Number: EMA/CHMP/414368/2021