🇪🇺 Infliximab biosimilar in European Union

EMA authorised Infliximab biosimilar on 10 September 2013

Marketing authorisations

Application: EMEA/H/C/002576
Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
Local brand name: Remsima
Indication: Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease?modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X?ray, has been demonstrated. Adult Crohn’s disease Remsim
Pathway: biosimilar
Status: approved

Application: EMEA/H/C/004020
Marketing authorisation holder: Samsung Bioepis NL B.V.
Local brand name: Flixabi
Indication: Rheumatoid arthritis Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. dult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1). Adult Crohn
Pathway: biosimilar
Status: approved

Is Infliximab biosimilar approved in European Union?

Yes. EMA authorised it on 10 September 2013; EMA authorised it on 26 May 2016.

Who is the marketing authorisation holder for Infliximab biosimilar in European Union?

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.