USFDAAug 3, 2026, 06:31 AM
Dr. Reddy's Receives U.S. FDA Approval for Rituximab Biosimilar
AI Summary
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 significantly strengthens the company's global biosimilars portfolio and advances its business in the United States. Under a commercialization agreement, Fresenius Kabi will exclusively commercialize the product in the U.S. The rituximab biosimilar has already been commercialized in India, the European Union, the United Kingdom, and over 25 emerging markets.
Key Highlights
- Dr. Reddy's Laboratories received U.S. FDA approval for its rituximab biosimilar.
- The approval strengthens Dr. Reddy's global biosimilars portfolio and U.S. business.
- Fresenius Kabi holds exclusive rights to commercialize the product in the United States.
- Approval follows a successful U.S. FDA Pre-License Inspection at the Hyderabad biologics facility.
- Rituximab biosimilar is already commercialized in India, EU, UK, and over 25 emerging markets.
- Rituximab is used to treat B-cell malignancies and certain autoimmune conditions.
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