Dr. Reddy's prepare to file for Rituxan biosimilar in US, EU as trials completed
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Dr. Reddy's Laboratories (NYSE:RDY) said it successfully completed the full set of DRL_RI, a potential biosimilar of Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) and Biogen's (BIIB) blockbuster drug Rituxan (rituximab), for filing in markets including the U.S., Europe and other regions.

The Indian drugmaker said DRL_RI is being developed as a biosimilar of rituximab for various indications which include treatment of adults with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Dr. Reddy's noted that rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
The company undertook further clinical studies â RI-01-003, RI-01-006 (FLINTER) and RI-01-007 â to meet regulatory requirements of highly regulated markets and is now preparing to file applications in the U.S. and EU and other regions globally.
Dr. Reddy's added that it collaborating with its partner Fresenius Kabi, a unit of Fresenius Medical Care (FMS), to commercialize the biosimilar in the U.S.
Dr. Reddy's plans to sell the product in Europe and other geographies directly.