Dr Reddy’s has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate DRL_RI for filing in the United States (US), Europe and other regions, a company statement said.
It stated that DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the US, European Union (EU) 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 statement further noted.
With the successful completion of these clinical studies, Dr Reddy’s is now preparing to file Biologics Licence Application (BLA)/Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally, it mentioned.
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