EMA Recommends Granting a Marketing Authorisation for Biosimilar Rituximab

In haematology it is intended for the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia

On 15 December 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the biosimilar medicine Truxima (biosimilar rituximab), intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.

Truxima will be available as a 500 mg concentrate for solution for infusion. The active substance of Truxima 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.

Truxima is a biosimilar 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 Truxima to have comparable quality, safety and efficacy to Mabthera.

The full indications in haematology are:

“Non-Hodgkin’s lymphoma (NHL)

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

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

Truxima 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.

Truxima 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.

Chronic lymphocytic leukaemia (CLL)

Truxima 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 Truxima or patients refractory to previous Truxima plus chemotherapy.”

It is proposed that Truxima be administered under the close supervision of an experienced healthcare professional and in an environment where full resuscitation facilities are immediately available.

Detailed recommendations for the use of this product 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.

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