Dr. Reddy’s Receives Positive CHMP Opinion From European Medicines Agency for Its Proposed Rituximab Biosimilar
Dr. Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in
DRL_RI is being developed as a biosimilar of MabThera® (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. ITUXREDI® / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera® and the intended indications are the same as those currently approved for MabThera®: Non–Hodgkin’s Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV).
EMA reference product, MabThera®, is a registered trademark of Roche.
About Dr. Reddy’s biosimilars programme:
Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 25 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a portfolio of commercial products in
About Dr. Reddy’s: Dr. Reddy’s
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INVESTOR RELATIONS
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Source: Dr. Reddy’s