FDA Accepts BLA for Dr. Reddy’s Rituximab Biosimilar for Review

On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN (rituximab).  RITUXAN is currently FDA-approved for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.  Dr. Reddy’s is collaborating with Fresenius Kabi to commercialize its proposed biosimilar of rituximab in the United States.

According to the press release, applications for Dr. Reddy’s rituximab biosimilar have previously been accepted for review by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).  The biosimilar has already been approved for marketing in multiple markets, including India.