Dr. Reddy’s Ituxredi (Biosimilar, MabThera) Receives the CHMP’s Positive Opinion
Shots:
- The CHMP has granted a positive opinion to DRL_RI (Ituxredi), a biosimilar of MabThera (rituximab)
- The approval, if granted, would be applicable across the whole EU plus Norway, Iceland & Liechtenstein. A separate MAA will be submitted to the MHRA as per reliance route under the IRP
- Ituxredi (CD20 directed cytolytic Ab) is for the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA) & Microscopic Polyangiitis (MPA) as well as Pemphigus Vulgaris (PV)
Ref: Alvotech | Image: Alvotech
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com