Dr. Reddy’s Laboratories Secures U.S. FDA Approval for Rituximab Biosimilar

Dr. Reddy’s Laboratories Limited has received approval from the U.S. Food and Drug Administration (US FDA) for its rituximab biosimilar, a biosimilar version of Rituxan® (rituximab), marking a major milestone in the company’s global biosimilars business. The approval strengthens Dr. Reddy’s presence in the highly regulated U.S. pharmaceutical market and reinforces its commitment to expanding access to complex biologic therapies.

Key Highlights of the Approval

• Regulatory Authority: U.S. Food and Drug Administration (US FDA)
• Product Approved: Rituximab biosimilar (biosimilar to Rituxan®)
• Developer and Manufacturer: Dr. Reddy’s Laboratories Limited
• Manufacturing Facility: Company’s biologics manufacturing facility in Hyderabad, India
• Commercialization Partner (U.S.): Fresenius Kabi holds exclusive commercialization rights in the United States.

The approval follows a successful Pre-License Inspection (PLI) conducted by the US FDA at Dr. Reddy’s biologics manufacturing facility, validating the company’s manufacturing capabilities and quality standards.

Approved Indications

Rituximab is a monoclonal antibody that targets the CD20 protein on B-cells and is used to treat several serious diseases, including:

• Non-Hodgkin lymphoma (NHL)
• Chronic lymphocytic leukemia (CLL)
• Rheumatoid arthritis (RA)
• Granulomatosis with polyangiitis (GPA)
• Microscopic polyangiitis (MPA)

The US FDA approval was supported by comprehensive analytical, preclinical, and clinical studies demonstrating that the biosimilar has no clinically meaningful differences from the reference product in terms of safety, efficacy, purity, and potency.

Expanding Global Biosimilars Portfolio

The newly approved biosimilar adds to Dr. Reddy’s growing global biosimilars portfolio. The company’s rituximab biosimilar is already marketed in:

• India
• European Union
• United Kingdom
• More than 25 emerging markets

In addition, the product has received marketing approvals in Switzerland and Canada, further expanding its international footprint.

Strategic Importance

The US FDA approval represents another significant achievement in Dr. Reddy’s biologics strategy. Entry into the U.S. market for a complex biosimilar enhances the company’s position in the global biosimilars industry and opens opportunities in one of the world’s largest pharmaceutical markets.

With Fresenius Kabi responsible for commercialization in the United States, Dr. Reddy’s is well positioned to expand patient access to cost-effective biologic therapies while strengthening its long-term growth prospects in regulated markets.