Shots:
- The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy’s Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements
- Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for several hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, CLL, RA, GPA, and MPA
- Under an exclusive commercialization agreement, Fresenius Kabi will commercialize the biosimilar in the U.S., while Dr. Reddy’s Laboratories developed, manufactured, and submitted it for approval
Ref: Fresenius Kabi | Image: Fresenius Kabi & Dr Reddy’s | Press Release
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