On the 21st April 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.
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
- 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].