- 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 — RI-01-003, RI-01-006 (FLINTER) and RI-01-007 — 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.
For further details see:
Dr. Reddy's prepare to file for Rituxan biosimilar in US, EU as trials completed