Dr. Reddy’s Laboratories Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its rituximab biosimilar, DRL_RI (ITUXREDI®), for launch in European markets. This positive opinion marks a significant step towards expanding access to affordable treatment options for patients across Europe.
What is Rituximab and How Does it Work?
Rituximab is a monoclonal antibody that targets a protein called CD20 found on the surface of certain types of B-cells, a type of white blood cell. By binding to CD20, rituximab triggers the body’s immune system to destroy these cells, making it an effective treatment for various conditions involving abnormal B-cell activity.
Approved Indications for Dr. Reddy’s Rituximab Biosimilar
DRL_RI (ITUXREDI®) is proposed as a biosimilar to MabThera® (Rituximab) and is intended for the same indications, including:
- Non-Hodgkin’s Lymphoma (NHL): A group of cancers that develop in the lymphatic system.
- Chronic Lymphocytic Leukemia (CLL): A type of cancer that affects the blood and bone marrow.
- Rheumatoid Arthritis (RA): A chronic inflammatory disorder affecting the joints.
- Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA): Rare diseases causing inflammation of blood vessels.
- Pemphigus Vulgaris (PV): A rare autoimmune skin disorder characterized by blisters.
The Road to European Approval and Beyond
Following the positive CHMP opinion, the European Commission (EC) will review the application. A final decision on marketing authorization in the EU member countries, as well as the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein, is expected shortly. A separate application will be submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Dr. Reddy’s Commitment to Biosimilars
Dr. Reddy’s has a long-standing commitment to developing and providing access to high-quality biosimilars. With over 25 years of experience in biologics, Dr. Reddy’s boasts a fully integrated organization capable of developing, manufacturing, and commercializing a range of biosimilar products in oncology and immunology. They already market several biosimilar products in India and over 25 other countries, with a strong pipeline of products in various stages of development for global launch.
The recent acceptance of the rituximab biosimilar application for review by the US FDA, EMA, and MHRA in July 2023, coupled with the earlier launch of Versavo® (bevacizumab) in the UK, highlights Dr. Reddy’s dedication to expanding its biosimilar portfolio and improving global access to these vital treatments.
In conclusion, the positive CHMP opinion for Dr. Reddy’s rituximab biosimilar represents a significant milestone in the effort to provide more affordable treatment options for patients in Europe. For personalized treatment plans, consult with a healthcare professional today.
