🇪🇺 Rituximab Biosimilar in European Union

EMA authorised Rituximab Biosimilar on 1 April 2020

Marketing authorisation

EMA — authorised 1 April 2020

  • Application: EMEA/H/C/004696
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Ruxience
  • Indication: Ruxience is indicated in adults for the following indications: Non?Hodgkin’s lymphoma (NHL) Ruxience is indicated for the treatment of previously untreated patients with stage III?IV follicular lymphoma in combination with chemotherapy. Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Ruxience monotherapy is indicated for treatment of patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Ruxience is indicated for the treatment of patients
  • Pathway: biosimilar
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Rituximab Biosimilar approved in European Union?

Yes. EMA authorised it on 1 April 2020.

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

Pfizer Europe MA EEIG holds the EU marketing authorisation.