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# Dr. Reddy’s Rituxan Biosimilar BLA Accepted
- URL: https://www.fdaweb.com/dr-reddys-rituxan-biosimilar-bla-accepted/
- Published: 2023-07-13T12:00:00.000Z
- Updated: 2026-09-14T18:44:02.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154874

FDA has accepted for review a Dr. Reddy’s Laboratories BLA for its proposed biosimilar rituximab (Genentech’s Rituxan) candidate, indicated for treating adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Reddy’s says its submission contains a comprehensive data package including “robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and U.S. reference products.”

According to Dr. Reddy’s, the biosimilar has already been approved in India and over 25 emerging markets. It is also collaborating with partner Fresenius Kabi to commercialize its proposed rituximab biosimilar in the U.S.