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Blitzima (rituximab)

Biosimilar
Region
🇪🇺 EU
Active substance
rituximab
Company
Celltrion Healthcare Hungary Kft.
Status
Authorised
Therapeutic area
Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
CHMP opinion
Thu 18 May 2017
EU approval
Thu 13 Jul 2017
Designations
Biosimilar
Application
EMEA/H/C/004723
ATC
L01FA01
Official record
www.ema.europa.eu

Indication

Blitzima is indicated in adults for the following indications: 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 CLL. 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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.