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
Related News:- Alvotech Reports Data from the Trial of AVT03 (Biosimilar, Prolia and Xgeva) for Skeletal Diseases
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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, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
