Dr Reddys receives USFDA approval for rituximab biosimilar

Dr. Reddy's Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the U.S. market. The approval further strengthens Dr. Reddy's growing global biosimilars portfolio and advances its biosimilars business in the United States.

The product was developed, manufactured and submitted for approval by Dr. Reddy's Laboratories. The approval follows the successful recent Pre-License Inspection (PLI) conducted by the U.S. FDA at the Company's biologics manufacturing facility in Bachupally, Hyderabad, and reflects the company's capabilities in bringing complex biologic medicines to highly regulated markets and its long-standing commitment to biosimilars.

 

Under a commercialization agreement, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States, one of the world's most important pharmaceutical markets.