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

On the 21^st 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.

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

Reference:

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].