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Dr. Reddy's Laboratories Says US FDA Approves Rituximab Biosimilar for US Market

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Dr. Reddy's Laboratories (RDY) said in a regulatory filing that the US Food and Drug Administration has approved its rituximab biosimilar for the US market.

The approval follows a recent Pre-License Inspection done by the US FDA at the biologics manufacturing plant in Hyderabad, India, the company said in a statement filed Monday.

Dr. Reddy's said that under a commercialization deal, Fresenius Kabi has the exclusive rights to commercialize the product in the US.

Rituximab is approved in the US to treat adults with blood cancers and autoimmune diseases including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, the company said.

Price: $12.10, Change: $+0.25, Percent Change: +2.11%

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