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.
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.
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.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.
Published on: Jul 29, 2024, 6:09 PM IST
We're Live on WhatsApp! Join our channel for market insights & updates
Get the link to download the App
