Dr. Reddy's Wins FDA Approval for Rituximab Biosimilar, Expanding U.S. Biologics Portfolio
The Indian drugmaker's biosimilar to Rituxan marks its latest FDA approval, with commercialization rights granted to Fresenius Kabi for the U.S. market.
FDA Grants Approval on Target Date
Dr. Reddy's Laboratories Limited disclosed in a 6-K filing that the U.S. Food and Drug Administration has approved its rituximab biosimilar, a biosimilar to Rituxan® (rituximab), for the U.S. market (6-K filing, 2026-08-03). The approval was granted on the FDA's goal date, according to the company's press release.
The Hyderabad-based pharmaceutical company developed, manufactured and submitted the product for approval independently. The approval followed a successful Pre-License Inspection conducted by the U.S. FDA at the company's biologics manufacturing facility in Bachupally, Hyderabad (6-K filing, 2026-08-03).
Commercialization and Market Reach
Under a commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the product in the United States (6-K filing, 2026-08-03). The rituximab biosimilar has already been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, and has received marketing approval in Switzerland and Canada (6-K filing, 2026-08-03).
The company launched its rituximab biosimilar in Europe in 2025, according to its filing. The U.S. represents one of the world's most important pharmaceutical markets for biosimilar products.
Clinical Profile and Indications
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B-cells, inducing B-cell depletion through multiple immune-mediated mechanisms (6-K filing, 2026-08-03). In the United States, rituximab is approved for treating adults with several hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis (6-K filing, 2026-08-03).
The FDA approval is supported by analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity and potency, consistent with FDA requirements for biosimilar approval (6-K filing, 2026-08-03).
Growing Biologics Capabilities
"The approval of the rituximab biosimilar on the FDA's goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets," said Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy's Laboratories (6-K filing, 2026-08-03).
The company's biologics division has developed over 25 years into a fully integrated organization with capabilities spanning development, manufacturing and commercialization. Dr. Reddy's currently markets six commercial biosimilar products in India, with some products marketed in more than 30 other countries (6-K filing, 2026-08-03). The company is ramping up manufacturing capacity to support global expansion plans.
MarginX data shows Dr. Reddy's is expected to report First-Half 2027 results on October 30, 2026. The company trades on BSE (500124), NSE (DRREDDY), NYSE (RDY) and NSE IFSC (DRREDDY), with a market capitalization of approximately $10 billion and last closing price of 1169.9.
This article was generated by MarginX from the 6-K filing on 2026-08-03. It is not investment advice.