European Medicines Agency recommends MabThera biosimilar for multiple indications
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Key takeaways:
- The committee recommended the launch of Ituxredi as a biosimilar of MabThera.
- Ituxredi will be indicated for many conditions including pemphigus vulgaris, granulomatosis with polyangiitis and more.
The European Medicines Agency Committee for Medicinal Products for Human Use has recommended the launch of proposed biosimilar rituximab candidate Ituxredi, Dr. Reddy’s Laboratories announced in a press release.
Ituxredi (DRL_RI), developed as a biosimilar of MabThera (rituximab, Roche), is a cluster of differentiation 20 directed cytolytic antibody intended to treat the same conditions that are approved for MabThera including pemphigus vulgaris, microscopic polyangiitis, granulomatosis with polyangiitis, rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.
Per the approval process, the European Commission will review the committee’s positive opinion and will determine whether to grant the biosimilar a marketing authorization in the European Union.
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