Dr. Reddy's Laboratories gets USFDA’s approval for rituximab biosimilar

Dr. Reddy's Laboratories has received approval from U.S. Food and Drug Administration (USFDA) for its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the U.S. market. The approval further strengthens its growing global biosimilars portfolio and advances its biosimilars business in the United States. Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B-cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.

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 USFDA 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.  The rituximab biosimilar has been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, and has also received marketing approval in Switzerland and Canada.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.