The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Rituximab biosimilar, riximyo, given ‘positive opinion’ by the EMA CHMP for use in Follicular and Diffuse Large B-Cell Lymphoma

May 3, 2017

On the 21 stApril 2017, the European Medicines Agency(EMA) Committee for Medicinal Products for Human Use ( CHMP) gave a positive opinion for granting marketing authorization for riximyo, a rituximab biosimilar monoclonal antibody targeting CD20 on B-cells.

The marketing approval application for riximyo was submitted by Sandoz GmbH. The CHMP concluded that riximyo shows “comparable quality, safety, and efficacy to Mabthera® (rituximab)” from Roche.

Riximyo will be available as 500mg and as a 100mg concentrate for solution for infusion. The full indication for riximyo is listed below:

Non-Hodgkin lymphoma (NHL)

  • Riximyo is indicated for the treatment of previously untreated patients with stage III-IV FL in combination with chemotherapy
  • Riximyo maintenance therapy is indicated for the treatment of FL patients responding to induction therapy
  • Riximyo monotherapy is indicated for treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy
  • Riximyo is indicated for the treatment of patients with CD20 positive DLBCL in combination with CHOP chemotherapy

  1. European Medicines Agency; Committee for Medicinal Products for Human Use. Summary of opinion (initial authorisation) – Riximyo (rituximab). 2017 Apr 21. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004729/WC500226218.pdf. [Accessed 2017 May 02].