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

20 Jan 2023 , 01:16 PM

Dr Reddy’s Laboratories Ltd on Friday 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.

At around 1:22 PM, global pharma major Dr Reddy’s was trading at Rs4344.15 per share higher by 0.29% on the BSE.

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, the company informed in a filing with the stock exchanges.

Notably, 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. 

Further, 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 Jayanth Sridhar, Global Head of Biologics at 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 to patients across the globe.” 

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