Dr Reddy’s Receives Positive CHMP Opinion for Biosimilar Rituximab

Dr Reddy’s Laboratories announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending the approval of its biosimilar Rituximab candidate, DRL_RI (ITUXREDI®), for the European market.

This positive CHMP opinion is a significant milestone for Dr Reddy’s, paving the way for the potential commercialisation of ITUXREDI® in the European Union (EU) and European Economic Area (EEA) countries. The company has already secured a Good Manufacturing Practice (GMP) certificate for its Rituximab manufacturing facility in Hyderabad, India.

DRL_RI is a biosimilar to MabThera®, a monoclonal antibody targeting the CD20 antigen. It is indicated for various conditions, including non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, and pemphigus vulgaris.

The European Commission will make the final decision on granting marketing authorisation for ITUXREDI®. The CHMP’s recommendation is expected to be reviewed. Dr. Reddy’s will also submit a separate Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP).

The approval of ITUXREDI® marks a significant step forward for Dr Reddy’s in expanding its biosimilar portfolio and providing patients with access to high-quality, affordable treatment options.

About Dr. Reddy’s Biosimilars Programme

Dr. Reddy’s biosimilar 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.

About Dr Reddy’s Laboratories Ltd

Established in 1984, Dr. Reddy’s Laboratories Ltd is a global pharmaceutical company headquartered in Hyderabad. The company offers a portfolio of products and services

including APIs, generics, branded generics, biosimilars and OTC. It is committed to providing access to affordable and innovative medicines.

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