Europe’s CHMP Recommends Rituximab Biosimilar Approval

Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for a biosimilar version of rituximab for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). If approved by the European Commission, the biosimilar rituximab would be available as a 500 mg concentrate solution for infusion.

The hematologic indications for biosimilar rituximab include:

  • NHL
    • In combination with chemotherapy for previously untreated patients with stage 3 or 4 follicular lymphoma (FL)
    • Maintenance therapy for patients with FL who have responded to induction therapy
    • Monotherapy for patients with stage 3 or 4 FL who are resistant to chemotherapy or have relapsed ≥2 times following chemotherapy
    • In combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for patients with CD20-positive diffuse large B-cell NHL
  • CLL
    • In combination with chemotherapy for patients with previously untreated and relapsed/refractory CLL

The biosimilar rituximab also received support from CHMP for the treatment of non-rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis.

Source: European Medicines Agency news release, December 15, 2016.