🇪🇺 HULIO in European Union

EMA authorised HULIO on 17 September 2018

Marketing authorisation

Application: EMEA/H/C/004429
Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
Local brand name: Hulio
Indication: Juvenile idiopathic arthritis  Polyarticular juvenile idiopathic arthritis  Hulio 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). Hulio 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
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is HULIO approved in European Union?

Yes. EMA authorised it on 17 September 2018.

Who is the marketing authorisation holder for HULIO in European Union?

Biosimilar Collaborations Ireland Limited holds the EU marketing authorisation.