Pharmaceutical company Dr. Reddy's Laboratories Ltd (BSE:500124) (NSE:DRREDDY) (NYSE:RDY) (NSEIFSC:DRREDDY) announced on Friday that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI.
DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody 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, but further clinical development was necessary to meet regulatory requirements of highly regulated markets such as the United States and Europe.
The company is now preparing to file Biologics License Application (BLA)/Marketing Authorisation Application (MAA) documents with various regulatory authorities globally.
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