ABLE Member, Dr Reddy’s Laboratories Ltd, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.

DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the United States, European Union and other regions for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company undertook further clinical development to meet regulatory requirements of highly regulated markets. With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally.

Dr. Reddy’s is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the US. The company intends to commercialize the product in Europe and other geographies directly.

Dr. Reddy’s successfully completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe