🇪🇺 Biosimilar in European Union

EMA authorised Biosimilar on 23 June 2017

Marketing authorisation

Application: EMEA/H/C/004192
Marketing authorisation holder: Sandoz GmbH
Local brand name: Erelzi
Indication: Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease?modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combina
Pathway: biosimilar
Status: approved

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

Is Biosimilar approved in European Union?

Yes. EMA authorised it on 23 June 2017.

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

Sandoz GmbH holds the EU marketing authorisation.