HYDERABAD, India, Aug. 1, 2026
Dr. Reddy’s Laboratories Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar, a biosimilar to Rituxan® (rituximab), for commercialization in the United States. The approval represents a significant milestone for the company’s expanding global biosimilars portfolio and further strengthens its position in the U.S. biologics market. Developed, manufactured, and submitted entirely by Dr. Reddy’s, the biosimilar received approval following a successful FDA Pre-License Inspection (PLI) of the company’s biologics manufacturing facility in Bachupally, Hyderabad. The approval highlights Dr. Reddy’s growing expertise in developing and manufacturing complex biologic medicines while reinforcing its long-term commitment to increasing global access to affordable, high-quality biosimilars.
FDA Approval Reinforces Manufacturing Excellence and Global Expansion
The FDA approval was supported by a comprehensive package of 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, or potency, meeting all regulatory standards required for biosimilar approval. Under an existing commercialization agreement, Fresenius Kabi will hold the exclusive rights to commercialize the rituximab biosimilar throughout the United States. According to Dr. Reddy’s, the approval reflects the company’s advanced biologics manufacturing capabilities and its continued investment in delivering complex biologic therapies to highly regulated global markets. The product has already been commercialized across India, the European Union, the United Kingdom, and more than 25 emerging markets, while also receiving marketing approvals in Switzerland and Canada, demonstrating its broad international regulatory acceptance.
Rituximab Biosimilar Supports Treatment of Cancer and Autoimmune Diseases
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B lymphocytes, leading to B-cell depletion through multiple immune-mediated mechanisms. In the United States, rituximab is approved for treating several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL), as well as autoimmune disorders such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). The approval of Dr. Reddy’s biosimilar is expected to improve access to biologic therapy by providing an additional treatment option that maintains the same standards of quality, safety, and efficacy as the reference medicine while supporting broader healthcare affordability. The approval also reinforces the growing role of biosimilars in expanding patient access to life-saving biologic therapies across oncology and immunology.
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Approval Advances Dr. Reddy’s Long-Term Biosimilars Growth Strategy
The latest FDA approval further advances Dr. Reddy’s Laboratories’ long-term strategy of becoming a leading global biosimilars developer. Over the past 25 years, the company’s biologics division has evolved into a fully integrated organization with strong capabilities across research, development, manufacturing, and commercialization. Its biosimilars portfolio currently includes multiple commercial products in oncology and immunology marketed across more than 30 countries, alongside an expanding pipeline targeting both developed and emerging markets. Recent milestones, including the launch of Versavo® (biosimilar bevacizumab) in the United Kingdom, pegfilgrastim commercialization through global partners, and now FDA approval of the rituximab biosimilar, underscore the company’s continued momentum in biologics. With Fresenius Kabi leading U.S. commercialization, the newly approved rituximab biosimilar is expected to play an important role in strengthening Dr. Reddy’s presence in one of the world’s largest pharmaceutical markets while supporting future global biosimilar expansion.
Source: Dr. Reddy’s Laboratories press release
