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Dr. Reddy’s Receives Positive EMA Opinion for Rituximab Biosimilar

NextEdge Admin

29 Jul 2024

2 min 26 sec

Immunotherapy,Oncology,autoimmune diseases,Dr Reddy's Laboratories

Dr. Reddy’s Laboratories Ltd has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the launch of its proposed biosimilar rituximab candidate, Ituxredi (DRL_RI), in European markets. The company’s manufacturing facility in Hyderabad, India, has already been awarded the EU GMP certificate for producing rituximab drug substances and products. Following the CHMP's positive opinion, the European Commission (EC) will review the recommendation to decide on marketing authorisation in EU member countries and the European Economic Area (EEA) states of Norway, Iceland, and Liechtenstein. A separate Marketing Authorisation Application (MAA) will be submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) via the International Recognition Procedure (IRP).

Ituxredi is a biosimilar of Roche's MabThera (rituximab), intended for the same indications: non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and pemphigus vulgaris (PV). In July 2023, the biosimilar application was accepted for review by the US FDA, EMA, and MHRA. Earlier in the year, Dr. Reddy's launched its first biosimilar in the UK, Versavo (bevacizumab).

Dr. Reddy’s biosimilars business is a strategic focus for the company, aiming to drive both short- and long-term growth. With 25 years of experience, its biologics team has developed robust capabilities in biosimilar development, manufacture, and commercialization in oncology and immunology. The company markets products in over 25 countries and is expanding its manufacturing capacity to support global expansion plans.