Bad Homburg, Germany, August 3, 2026
Fresenius Kabi, an operating company of Fresenius, announced that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy’s Laboratories, marking an important expansion of Fresenius Kabi’s biosimilars portfolio in the United States. The newly approved medicine is a biosimilar to Rituxan® (rituximab), an established monoclonal antibody used across several hematologic malignancies and autoimmune diseases. Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the rituximab biosimilar in the U.S. market, while Dr. Reddy’s Laboratories developed, manufactured and submitted the product for FDA approval.
FDA Approval Strengthens U.S. Biosimilars Portfolio
The FDA approval represents a significant regulatory milestone for Fresenius Kabi as the company continues to strengthen its presence in the U.S. biosimilars market. According to Fresenius Kabi, the rituximab biosimilar strategically complements its existing oncology and immunology portfolios and supports its objective of expanding access to high-quality and more affordable biologic medicines. The FDA decision was based on a totality-of-the-evidence approach, including analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to the reference medicine, Rituxan, with no clinically meaningful differences identified in accordance with U.S. regulatory requirements for biosimilar approval. The development program incorporated comprehensive analytical characterization alongside non-clinical, pharmacokinetic and clinical studies designed to establish biosimilarity. Dr. Reddy’s Laboratories was responsible for the development and manufacturing of the product, while Fresenius Kabi will use its U.S. commercial infrastructure to bring the biosimilar to the market.
Rituximab Targets CD20 Across Cancer and Autoimmune Diseases
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B lymphocytes. Binding to CD20 results in B-cell depletion through multiple immune-mediated mechanisms, making rituximab an important therapeutic option across several B-cell malignancies and autoimmune disorders. In the United States, rituximab is used in adults for conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. The availability of another FDA-approved biosimilar provides an additional option within a therapeutic area where biologic medicines play an important role in long-term patient management. Biosimilars are developed to demonstrate high similarity to an FDA-approved reference biologic and must meet regulatory standards showing that there are no clinically meaningful differences in safety, purity and potency compared with the reference product.
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Fresenius Kabi Expands Biopharma and Biosimilar Strategy
The rituximab approval also advances Fresenius’ broader #FutureFresenius biopharma strategy, under which biopharmaceuticals represent a core growth pillar. Fresenius is building a vertically integrated, end-to-end biopharma organization spanning research and development, manufacturing and global commercialization. The company aims to combine technical development capabilities, global production expertise and commercial infrastructure to increase access to complex biologic therapies. Fresenius Kabi already maintains a broad healthcare portfolio covering biopharmaceuticals, oncology, autoimmune and endocrine diseases, clinical nutrition, medical technology, intravenous generic medicines and fluids. With operations in more than 100 countries and over 41,000 employees, the company says its portfolio reaches approximately 450 million patients annually. The FDA approval of the Dr. Reddy’s-developed rituximab biosimilar adds another established biologic molecule to Fresenius Kabi’s growing U.S. biosimilars business and strengthens its positioning in oncology and immunology. The exclusive U.S. commercialization arrangement also illustrates how development and manufacturing partnerships can support the expansion of biosimilar availability in major pharmaceutical markets. For Fresenius Kabi, the regulatory milestone represents another step toward building a broader portfolio of high-quality, affordable biologic medicines while expanding its presence across the U.S. biopharmaceutical market.
Source: Fresenius Kabi press release
