Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Telugu Super News,Hyderabad, India;January 23, 2023–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company,
announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar
candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.
DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic
antibody for approval in the United States, European Union and other regions for various indications including
treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia,
pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging
markets. The company undertook further clinical development to meet regulatory requirements of highly
regulated markets. With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file
Biologics License Application (BLA)/Marketing Authorisation Application (MAA) dossiers with various regulatory
authorities globally.
Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “This is a very important milestone in
our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our
capability for global clinical development of biosimilar products for highly regulated and global markets. These
results underscore our commitment to developing high quality biosimilarsand reinforce the potential of DRL_RI
as a safe and effective treatment option to patients across the globe.”
Dr. Reddy’s is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of
rituximab in the United States. The company intends to commercialise the product in Europe and
othergeographies directly.