Dr Reddy’s completes clinical studies of its rituximab biosimilar for filing in the US, Europe

Hyderabad: The full set of clinical studies of Dr Reddy’s Laboratories Ltd (Dr Reddy’s) proposed rituximab biosimilar candidate, DRL_RI, has been completed successfully. Rituximab biosimilar clinical studies are for filing in highly regulated markets such as the United States, Europe, and other regions; the pharmaceutical company.

Dr Reddy’s rituximab biosimilar has already been approved for marketing in India. According to the company, it undertook further clinical development to meet the 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.

Commenting on this development, Dr Jayanth Sridhar, Global Head of Biologics, Dr Reddy’s said, "This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets. These results underscore our commitment to developing high-quality biosimilars and reinforce the potential of DRL_RI as a safe and effective treatment option for patients across the globe."

According to the company, 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 is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.