Three Biosimilar Medicines with Rituximab as Active Substance Received a Positive Opinion from EMA

In haematology, Blitzima and Tuxella are indicated for the treatment of non-Hodgkin's lymphoma and CLL, while Ritemvia is indicated in non-Hodgkin's lymphoma

On 18 May 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending granting a marketing authorisation for three biosimilar medicines with rituximab as their active substance. In haematology, Blitzima is intended for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL); Ritemvia is intended for the treatment of NHL; and Tuxella is intended for the treatment of NHL and CLL.

The applicant for these medicinal products is Celltrion Healthcare Hungary Kft.

Blitzima

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

Blitzima is a biosimilar medicinal product. It is highly similar to the reference product Mabthera (rituximab), which was authorised in the EU on 2 June 1998. Data show that Blitzima has comparable quality, safety and efficacy to Mabthera.

The indications in haematology are:

Non-Hodgkin’s lymphoma (NHL)

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

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

Blitzima 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.

Blitzima 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)

Blitzima 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 Blitzima or patients refractory to previous Blitzima plus chemotherapy.

It is proposed that Blitzima 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 (SmPC), which will be published in the European public assessment report (EPAR) 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.

Ritemvia

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

Ritemvia is a biosimilar medicinal product. It is highly similar to the reference product Mabthera (rituximab), which was authorised in the EU on 2 June 1998. Data show that Ritemvia has comparable quality, safety and efficacy to Mabthera.

The full indications in haematology are:

Non-Hodgkin’s lymphoma (NHL)

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

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

Ritemvia 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.

Ritemvia 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.

It is proposed that Ritemvia 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 SmPC, which will be published in the EPAR 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.

Tuxella

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

Tuxella is a biosimilar medicinal product. It is highly similar to the reference product Mabthera (rituximab), which was authorised in the EU on 2 June 1998. Data show that Tuxella has comparable quality, safety and efficacy to Mabthera.

The full indications in haematology are:

Non-Hodgkin’s lymphoma (NHL)

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

Tuxella 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.

Tuxella 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)

Tuxella 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 Tuxella or patients refractory to previous Tuxella plus chemotherapy.

It is proposed that Tuxella 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 SmPC, which will be published in the EPAR 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.