Dr. Reddy's Rituximab Biosimilar Approved by US FDA
Dr. Reddy's Laboratories received U.S. FDA approval for its rituximab biosimilar on August 1, 2026. The product, developed and manufactured by Dr. Reddy's, will be exclusively commercialized in the U.S. by Fresenius Kabi. This approval strengthens Dr. Reddy's biosimilars portfolio.
FDA approval for a major market like the U.S. for a biosimilar product is a significant event that can lead to substantial revenue and market share growth.
The FDA approval of a biosimilar is a positive development for the company, expanding its product portfolio and market presence.
Dr. Reddy's Laboratories Ltd. announced on August 1, 2026, that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar for the U.S. market. This approval is a significant addition to Dr. Reddy's global biosimilars portfolio and strengthens its presence in the United States.
The rituximab biosimilar was developed, manufactured, and submitted for approval by Dr. Reddy's. The approval follows a successful Pre-License Inspection (PLI) by the U.S. FDA at the company's biologics manufacturing facility in Bachupally, Hyderabad. This highlights the company's capabilities in producing complex biologic medicines for highly regulated markets and its commitment to biosimilars.
Under a commercialization agreement, Fresenius Kabi will exclusively market the product in the United States. Sridevi Khambhampaty, Global Head of Biologics at Dr. Reddy's Laboratories, stated that the FDA approval on the target date demonstrates their expertise in developing and manufacturing complex biologic medicines for global markets.
The rituximab biosimilar has already been commercialized in India, the European Union, the United Kingdom, and over 25 emerging markets. It has also received marketing approval in Switzerland and Canada. Rituximab is a monoclonal antibody used to treat various B-cell malignancies, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.
The FDA approval is backed by extensive analytical, non-clinical, and clinical data, confirming the biosimilar's high similarity to the reference product with no clinically significant differences in safety, purity, and potency.
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Dr. Reddy's Laboratories Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it high impact, which is the band that most often changes something.
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See the model portfoliosA plain-language summary of a public exchange filing by Dr. Reddy's Laboratories Limited. Read the original for the full detail.