Dr. Reddy's Rituximab Biosimilar Receives Positive CHMP Opinion for EU Launch
核心洞察
Dr. Reddy's Laboratories has received a positive opinion from the EMA's CHMP for its proposed rituximab biosimilar, DRL_RI (ITUXREDI), paving the way for its launch in European markets.
The CHMP's positive opinion will be reviewed by the European Commission for marketing authorization in EU member countries and EEA states.
DRL_RI is developed as a biosimilar of MabThera (rituximab), a CD20 (搜索)-directed cytolytic antibody, targeting indications like NHL, CLL, RA, GPA/MPA, and PV.
Dr. Reddy's Laboratories Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the launch of its proposed rituximab biosimilar candidate DRL_RI (ITUXREDI) in European markets. This decision marks a significant step toward providing a more accessible treatment option for patients with conditions currently treated by the reference product, MabThera (rituximab).
Dr. Reddy’s had previously secured the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility in Hyderabad, India. The CHMP positive opinion will now undergo review by the European Commission (EC), which will then decide on granting marketing authorization within the European Union (EU) member countries, as well as the European Economic Area (EEA) member States of Norway, Iceland, and Liechtenstein.
ITUXREDI / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera. The intended indications mirror those currently approved for MabThera, including Non–Hodgkin’s Lymphoma (搜索) (NHL), Chronic Lymphocytic Leukaemia (搜索) (CLL), Rheumatoid Arthritis (搜索) (RA), Granulomatosis with Polyangiitis (搜索) (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (搜索) (MPA), and Pemphigus Vulgaris (搜索) (PV).
A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately, following the reliance route under the International Recognition Procedure (IRP). Rituximab, the reference product, is a cluster of differentiation 20 (CD20 (搜索)) directed cytolytic antibody. Biosimilars like DRL_RI aim to offer cost-effective alternatives while demonstrating comparable efficacy and safety profiles to the original biologic drug.