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