This medicine is authorised for use in the European Union.


Hulio is a medicine that acts on the immune system 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 X-ray does not show disease but there are clear signs of inflammation;
  • 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 (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).

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

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

This EPAR was last updated on 05/12/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Hidradenitis Suppurativa
  • Psoriasis
  • Uveitis
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
  • Crohn Disease
  • Colitis, Ulcerative
  • Arthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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.


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.

Publication details
Marketing-authorisation holder
Viatris Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Damastown Industrial Park 
Dublin 15 

Product information

05/12/2022 Hulio - EMEA/H/C/004429 - IB/0039

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Immunosuppressants

  • Tumor necrosis factor alpha (TNF-α) inhibitors

Therapeutic indication

Assessment history

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