EMA Recommends Approval of Two Biosimilar Medicines – Biosimilar Rituximab

In haematology, Rixathon is indicated for the treatment of NHL and CLL and Riximyo for the treatment of NHL

Rixathon

On 21 April 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal product Rixathon, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

The applicant for this medicinal product is Sandoz GmbH.

Rixathon will be available as a 500-mg and as a 100-mg concentrate for solution for infusion. The active substance of Rixathon is rituximab, a monoclonal antibody (ATC code: L01XC02) that binds specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In NHL and CLL, this promotes destruction of malignant B cells and thus controls tumour growth. In RA, GPA and MPA, it reduces B cells involved in their pathogenesis.

Rixathon is a biological medicinal product that is highly similar to the reference product Mabthera (rituximab), which was authorised in the EU on 2 June 1998. Studies have shown Rixathon to have comparable quality, safety and efficacy to Mabthera.

The indications in NHL are:

Rixathon is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.

Rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Rixathon monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Rixathon is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

The indication in CLL is:
Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rixathon or patients refractory to previous Rixathon plus chemotherapy.

Riximyo

On 21 April 2017, the EMA’s CHMP adopted a positive opinion, recommending granting a marketing authorisation for the medicinal product Riximyo, intended for the treatment of NHL, RA, GPA and MPA.
The applicant for this medicinal product is Sandoz GmbH.

Riximyo will be available as a 500-mg and as a 100-mg concentrate for solution for infusion. The active substance of Riximyo is rituximab, a monoclonal antibody (ATC code: L01XC02) that binds specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In NHL this promotes destruction of malignant B cells and thus controls tumour growth. In RA, GPA and MPA, it reduces B cells involved in their pathogenesis.

Riximyo is a biological medicinal product that is highly similar to the reference product Mabthera (rituximab), which was authorised in the EU on 2 June 1998. Studies have shown Riximyo to have comparable quality, safety and efficacy to Mabthera.

The indications in NHL are:

Riximyo is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.

Riximyo maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Riximyo monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma 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 diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Detailed recommendations for the use of these two products will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.