Dr Reddy's Gets US FDA Approval for Rituximab Biosimilar

Dr. Reddy's Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar for the U.S. market. This approval strengthens the company's global biosimilars portfolio and its presence in the U.S. pharmaceutical market. The biosimilar was developed, manufactured, and submitted by Dr. Reddy's, following a successful Pre-License Inspection (PLI) at its Hyderabad facility. Fresenius Kabi will exclusively commercialize the product in the United States under a separate agreement. The rituximab biosimilar is already commercialized in India, the EU, UK, and over 25 emerging markets, with marketing approvals in Switzerland and Canada.